Innovation Louisiana 2016 Conference Program

November 14 - 15
Presenting Sponsor:
NewOrleansBioInnovationCenter
6

Dear attendees,
I’d like to welcome you to the fourth Innovation Louisiana conference that we’ve held at the BioInnovation
Center. To me, the event’s continued growth is a prime example of both the caliber of research being done
across our state, as well as the impact entrepreneurship is having on the development of a life science
economy in Louisiana. There is increasing interest from around the country in the work we are doing, as
evidenced by the notable experts from more than ten states joining us this week to share expertise and help
connect you to resources around the country.
As you look at the agenda for this conference, you will see sessions that will help you hone your development
and business strategies, find funding sources, and connect to peers and potential mentors, partners, and
funders. This year, we’ve also added an emphasis on developing a clear understanding of the right market fit
and the needs of your eventual customers as you develop your innovations. We hope the panel discussions
and speakers we’ve lined up will provide beneficial insights, business skills training, and networking
opportunities to better prepare you to successfully commercialize novel technologies.
Of course, none of this would be possible without the generous support of our partners. We’ve been able to
attract support from a broad range of companies, all of which are adding value to our mission by committing
their resources toward the development and growth of our startups and businesses across our state.
The results of this work are becoming far-reaching. We are bringing more out-of-state investment to Louisiana
through federal and private grant support, we’re attracting outside equity investments, and we’re bringing
more and more professionals to Louisiana to help in the development of our life science ventures. All of
this comes together to help build workforce opportunities and increase the value of the world-changing
technologies that are being developed here in our state.
Collaboration among talented researchers, bright student inventors, experienced
entrepreneurs, and countless partners is propelling our state’s life sciences innovation
community forward. We hope you have an enriching experience at Innovation
Louisiana 2016, and we look forward to seeing where your commercialization
pathway leads you in the years to come.
Sincerely,
Aaron Miscenich
President, New Orleans BioInnovation Center
PAGE 2
Program Overview
Program Contents
Overview 2
Event Sponsors 3
Agenda 4
Other Special Events 8
Meet Our Speakers 9
Commercialization Glossary 14

Thanks to Our Sponsors
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P A R T N E R S

9:00am
Welcome and Introductory Remarks
9:20 - 10:30am
Lessons from Seasoned Biotech Entrepreneurs
Starting up a biotech company is a risky venture, but you can learn from the experiences of others who have
started and grown previous successful startups. Learn the best practices and common pitfalls to avoid from
startup executives with expertise in pharma, investing, and entrepreneurship.
Moderator: J. Lowry Curley, AxoSim Technologies
• Luis M. Branco, PhD
Co-Founder, Zalgen Labs LLC
• Sandra I. Coufal, MD
President, Sibling Capital LLC
• Randy Hubbell
President & CEO, Carmell Therapeutics
• William Wilkison, PhD
Chief Scientific Officer, Avolynt Inc.
• Brett Wingeier, PhD
Co-Founder & Chief Technical Officer, Halo Neuroscience
10:40 - 11:25am
The Life Cycle of a Biotech Startup
Whether developing a device, therapeutic, diagnostic, or other technology, most life sciences startups face
common milestones and commercialization hurdles. Get an integrative view of entrepreneurship in the space
and find out what young biotech companies can expect at various stages of development.
• Rob Tucci
Managing Director, Texas Halo Fund
11:30am - 12:30pm
Forming a Strong Founding Team
From leading strategy development to assuring investors of the company’s potential, the management team
at an early-stage startup is critical to its success. Learn about building the right foundation, setting up the ap-
propriate corporate structure, finding executives, and other steps that will affect future fundraising, valuations,
and more.
Moderator: David Bode, New Orleans BioInnovation Center
• Ben Cappiello
CEO & President, Bioceptive
• Bob Crutchfield
General Partner, Harbert Management Corporation
• William Wilkison, PhD
Monday, November 14

12:30pm – Networking Lunch
Sponsored by EY
1:30 - 2:30pm
Alternative Financing in the Life Sciences
Investment capital isn’t the only option for entrepreneurs seeking to fund proof of concept work, product
development, and commercialization. Learn about some alternative funding options both at the local and
national levels that can help you grow your business.
Moderator: Amritha Appaswami, New Orleans Business Alliance
• Luis M. Branco, PhD
• Gregory Davenport, PhD
Vice President, The Conafay Group
• Kory Hallett, PhD
Program Manager, National Cancer Institute Small Business Innovation Research Development Center
• Randy Hubbell
• Roy Keller
Director, Louisiana Technology Transfer Office
2:35 - 3:40pm
Angel Investment and Seed Funding
Convincing angel investors to fund biotech startups can be difficult, but you can take key steps to better
prepare your company for investment opportunities. Hear what angel investors are seeking in this space, how
they prefer to be approached, and ways to improve your chances of successfully landing early funding.
Moderator: Kris Khalil, New Orleans BioFund
• Faz Bashi, MD
Digital Health and Life Sciences Member, Life Science Angels
• Mike Eckert
Chairman, NO/LA Angel Network
• Meli James
Head of New Ventures, Sultan Ventures
• Cian C. Robinson
Executive Director, Lafayette General Foundation
• Rob Tucci
3:45 - 4:30pm
Keynote Address: Determining the Right Market
Sponsored by New Orleans Business Alliance
Creating a successful science-based business means finding product/market fit
while interpreting an ocean of data, simultaneously making headway on tough
technical problems, and constantly navigating uncertainty. Learn how Halo Neu-
roscience used data and careful planning to build the right product for the right
customers and create a business case for their company.
PAGE 5

9:00am
Opening Remarks
9:15 - 10:20am
Transforming Health Care in Louisiana and Beyond
The next phase in health innovation is all about facilitating the patient care experience and improving patient
outcomes. How are providers, industry groups, and payers working to invest in novel care approaches and
technologies in our fast-changing health care system? Our panelists will discuss how best to accelerate truly
innovative health care improvements both here in Louisiana and across the country.
Moderator: Aaron Miscenich, New Orleans BioInnovation Center
• Thomas Carton, PhD
Director, Health Services Research, Louisiana Public Health Institute
• Bill Masterton
President and CEO, University Medical Center New Orleans
• Robert S. Muscalus, DO
Medical Director, Care Transformation, Blue Cross and Blue Shield of Louisiana
• Cian C. Robinson
• Aimee Quirk
Chief Executive Officer, innovationOchsner
• Adam Zerda, PhD
Strategic Innovation & Business Development, BD
10:30 - 11:30am
Protecting Intellectual Property in the Life Sciences
Intellectual property is a critical source of value for early biotech startups. Learn about critical IP protection
issues from the perspectives of different stakeholders who have extensive knowledge of patenting and licens-
ing novel technologies.
Moderator: Ben Cappiello, Bioceptive, Inc.
• Richard Babb
Managing Partner, Louisiana Funds
• Paula Estrada de Martin, PhD
Registered Patent Attorney, Baker Donelson
• Hope Shimabuku
Director, U.S. Patent and Trademark Office Texas Regional Office
11:35am - 12:30pm
Understanding Your Customer: New Technology Adoption by Medical Providers
Physicians deal with numerous pressures and drivers that affect their decisions on whether to adopt new
technologies. What are some of these issues, and what do startups with new technologies need to do to
show value to providers and payers?
Tuesday, November 15

Moderator: Leigh Cosolito, New Orleans BioInnovation Center
• Abigail Chaffin, MD
Assistant Professor of Plastic Surgery, Tulane University
• Vinod Dasa, MD
Associate Professor, LSU Health New Orleans
• Robert S. Muscalus, DO
Medical Director, Care Transformation, Blue Cross and Blue Shield of Louisiana
• Korak Sarkar, MD
Neurologist, Ochsner Health System
12:30pm – Networking Lunch
Sponsored by BIO
1:30 - 2:35pm
Venture Capital in the Biosciences
Biotechnology product development can be a long, expensive process, and most startups will have to raise
significant capital to successfully commercialize their technologies. In this panel, national venture capital in-
vestors will discuss their funds, investment strategies, and timelines, as well as best practices in approaching
and working with venture capitalists.
Moderator: David Rieveschl, Baker Donelson
• Bob Crutchfield
• Joseph Lovett
Managing Director, Louisiana Funds
• Charlie Plauche
Principal, S3 Ventures
2:40 - 3:45pm
Developing Partnerships with Industry
Partnerships can be a crucial source of expertise, validation, and funding for emerging startups. Learn about
how several major international pharmaceutical and medical device companies approach early-stage partner-
ships, their primary areas of focus, and the partnering models they typically use with startups and research-
ers.
Moderator: Shafin Khan, New Orleans BioInnovation Center
• Joe Berglund, PhD
Manager, Pipeline, Strategy, & Business Analytics, Medtronic
• James Hoberg, PhD
Head of Licensing & External Innovation, MilliporeSigma
• Pamela Hornby, PhD
Senior Director and Fellow, Janssen R&D
• Joseph P. Simeone, PhD
Director, Business Development & Licensing, MRL, Merck
• Adam Zerda, PhD

Wednesday, November 16
The Joy Theater
LOUISIANA UNIVERSITY TECHNOLOGY SHOWCASE 9:00 - 11:00am
Network and learn about license-ready technologies in health, advanced materials, and more from:
BIOCHALLENGE PITCH COMPETITION 11:00am - 1:00pm
Selected from a pool of applicants from across the state, four finalist startups that are developing new drugs,
diagnostics, and other technologies pitch for over $50,000 in prizes.
Friday, November 18
TPC Louisiana Golf Course
NEW ORLEANS BIOFUND GOLF SCRAMBLE + NETWORKING BRUNCH 9:00am - 4:30pm
Join us for a team scramble-format tournament and an opportunity to network with the local investment
and innovation communities. The BioFund is a program of the BioInnovation Center that provides a range
of capital products to qualifying startups and small businesses in a range of industries who are seeking
funding for continued growth.
Delgado Community College
Louisiana State University
LSU AgCenter
LSU Health New Orleans
Louisiana Tech University
Nicholls State University
Tulane University
University of New Orleans
Xavier University of Louisiana
3:50 - 4:30pm
Keynote Address: Research Partnerships to Transform Clinical Innovation
The Michael J. Fox Foundation is dedicated to finding a cure for Parkinson’s dis-
ease through an aggressively funded research agenda and to ensuring the devel-
opment of improved therapies for those living with Parkinson’s today. Learn how
the Foundation partners with industry and academia on fostering new research
tools, better understanding Parkinson’s progression, and expediting research on
novel treatments, with the aim to not only fund research but also to help improve
the translational research environment itself.
• Rachel Rimsky
Associate Director, Research Partnerships, The Michael J. Fox Foundation for
Parkinson’s Research
4:30pm
Closing Networking Mixer
Presented in Partnership with the New Orleans BioFund
Join us for refreshments and networking with speakers and other attendees from around the region.
Other Special Events

RICHARD BABB
Mr. Babb has over 30 years of diverse business, account-
ing and financial management experience, having previously
been a Manager with Ernst & Young’s Entrepreneurial Ser-
vices Group handling various venture capital clients, having
been the Chief Financial Officer for Medical Science Partners,
a Harvard-affiliated life science venture capital fund, and
serving as the NASD Chief Compliance Officer, for Apeiron
Partners LLC. Richard holds a BS in Business Administra-
tion from American International College and is an inactive
Certified Public Accountant, and has NASD licenses Series
7, 24, 28 & 63.
FAZ BASHI
Digital Health and Life Sciences, Life Science Angels
Faz K. Bashi, MD, has a research background in Immunol-
ogy and Virology from UCSF. He is an active member of Life
Science Angel's (LSA) in Silicon Valley, as well as Chair of
the Angel Capital Association's (ACA) Life Sciences Syndica-
tion group. He was recently elected to serve as a Member of
the ACA Board of Directors. He served as the 2015 Chair of
LSA’s Digital Health & Sciences Screening Committee, 2013
Chair of LSA's Device Screening Committee, 2 years on the
LSA Board, and is a member of the Biotech/Pharma Screen-
ing Committee. He was a founding member of HealthTech
Capital where he served on the Board of Directors for a 2
year term. He is a member of Berkeley Angel Network. He
is active with UCSF’s Entrepreneurship Startup 101 and
Lean Launchpad, UCSFs CTSI external advisory board, and
Springboard Enterprises focused on women entrepreneurs.
He works as a consultant to Patient Visit Redesign on work-
flow process improvement for community health centers,
and safety net organizations across the US. He is active on
the Advisory Board of Tiatros-powered-by-Watson integrat-
ing physical and behavioral medicine. He volunteers his time
with Peninsula Bridge program to help the underserved kids
of East Palo Alto get inspired about their futures via educa-
tion. He is committed to helping find treatments for Tinnitus,
Autism, Lupus, and Vascular diseases. He completed several
triathlons with Team-In-Training to raise funds for the Leuke-
mia and Lymphoma Society.
JOSEPH BERGLUND
Manager, Pipeline, Strategy, and Business Analytics, Medtronic
Joe Berglund is a strategy manager in Medtronic’s Coronary
and Structural Heart business unit. During his eleven years
with the company, Joe has worked on a number of projects
including bioabsorbable drug-eluting stents and business
model innovation (BMI) initiatives. He received a bachelor’s
degree from Johns Hopkins University, a PhD in bioengineer-
ing from the Georgia Institute of Technology, and an MBA
from the University of Pennsylvania. Joe currently lives in
Santa Rosa, CA with his wife and two daughters.
LUIS M. BRANCO
Dr. Branco is a co-founder of Zalgen Labs, a biotech com-
pany dedicated to the development of rapid multiplex diag-
nostics, new vaccine and therapeutic platforms for emerging
and neglected viral diseases. He has extensive expertise in
multiple facets of research and development of chimeric,
humanized, human, and affinity maturation of recombinant
antibodies for human use; murine monoclonal antibody pro-
duction for a variety of soluble and cell-associated antigens;
Design of baculoviral, bacterial, and mammalian expression
systems for production of recombinant proteins, from small
to commercial scales. Over 20 years in industry, he has been
directly involved in the development of licensed antibody
therapeutics, including MedImmune’s Synagis (Palivizum-
ab), Human Genome Sciences’ Benlysta (Belimumab) and
ABthrax (raxibacumab), as well as additional antibodies un-
der clinical evaluation (MEDI’s Numax [motavizumab], HGS’
CCR5mAb004, HGS-ETR1 [Mapatumumab]). Zalgen Labs is
in essence an extension of his previous tenures in biotechnol-
ogy and academia (Tulane) with a focus on high impact viral
diseases with public health and biodefense relevance.
BENJAMIN D. CAPPIELLO
CEO & President, Bioceptive
Ben leads Bioceptive and is the founding inventor of the
startup’s core technologies. He devised the initial concept
while a student at Tulane University and brought together the
current team to found the company following his graduation.
Ben holds a BSE in Biomedical Engineering from Tulane.
He was previously an intern in adult stem cell engineering
at Boston Biomedical Research Institute in the laboratory of
the renowned researcher, James Sherley, MD, PhD. Ben is
an appointed board member of the Louisiana MediFund, an
advisory board member of Tulane’s BioInnovation PhD pro-
gram, and a member of the external constituent’s committee
for Tulane’s Department of Biomedical Engineering.
THOMAS W. CARTON
Director, Health Services Research, Louisiana Public Health In-
stitute
Thomas Carton, PhD, MS is the Director of Health Services
Research for the Louisiana Public Health Institute, where
he leads a portfolio that conducts various types of health
services research that span clinical research to social epi-
demiology. As Principal Investigator of the Research Action
for Health Network (REACHnet), he leads a multi-institution-
al and multi-disciplinary team that is creating a regional in-
formatics, patient engagement, and research infrastructure
to efficiently conduct pragmatic clinical trials nested within
the healthcare delivery system. In addition, he serves on the
Patient Centered Outcomes Research Network (PCORnet)
Research Committee, where he leads a research innova-
tions workgroup advancing electronically aided recruitment
Meet Our Speakers

for research registries and clinical trials, and he is a member
of an Agency for Healthcare Research and Quality Technical
Expert Panel outlining competencies for the next generation
of Learning Health System researchers, including leading the
competency on research management and innovations. He
is also an Adjunct Professor at Tulane University’s School of
Public Health, where he teaches Econometrics and advises
doctoral students.
ABIGAIL E. CHAFFIN
Assistant Professor of Plastic Surgery, Tulane University
Dr. Abigail Chaffin (MD) is a plastic and reconstructive sur-
geon at Tulane University. Her practice encompasses treat-
ment of plastic and reconstructive surgical conditions includ-
ing breast and abdominal wall reconstruction, wound care,
burn care and general reconstructive surgery. Her research
focuses on breast cancer with novel biologic constructs
for nipple-areolar reconstruction, novel techniques for im-
plant-based breast reconstruction, and adipocyte-derived
mesenchymal stem cells.
SANDRA I. COUFAL
Sandra Coufal (MD) is primarily engaged in managing the day-
to-day activities of Sibling Capital; operational due diligence;
processing and executing transactions; supporting and vet-
ting the firm’s investments; and business development. Prior
to co-founding Sibling, Dr. Coufal founded Relypsa’s Scientif-
ic Advisory Board and co-founded Ilypsa’s Scientific Advisory
Board. For the past 15 years, she has been the Biomedical
Advisor for the Genomics Institute of the Novartis Research
Foundation and continues in this role at the present time. She
is also on the Advisory Board of startup ReactWell LLC in
New Orleans. Most recently, Dr. Coufal has been a Founder
of Tricida, Inc., as well as a Member of the Board of Directors
and a Member of the Scientific Advisory Board. Over the past
3 years, Dr. Coufal, has been a major investor in the series
A and B funding for Tricida, Inc., through her co-founding
of venture firm Sibling Capital. Prior to pursuing a career in
biotechnology, Dr. Coufal was the Head of the Division of In-
ternal Medicine at the Torrey Pines site of Scripps Clinic in La
Jolla, CA. She also sat on the Board of Scripps Green Hos-
pital as the Representative-at-Large elected by the 300 phy-
sicians of Scripps Clinic Medical Group. Concurrently, she
served as Associate Faculty in the Division of Internal Medi-
cine for UCSD. She has been granted board certification by
the American Board of Internal Medicine on two occasions.
BOB CRUTCHFIELD
Mr. Crutchfield joined HMC in September 2008 and serves
on the Boards of Axial Exchange, CareSync and Shipt. He
also serves as the board observer for MaxCyte, Social Safe-
Guard and WiserTogether. In addition to his responsibilities
at Harbert, he is a member of the Board of Directors for the
Southern Capital Forum, Southeastern Medical Device As-
sociation, the Florida Venture Forum, the Innovation Depot
and the True Vine Foundation. He serves on the Board of Ad-
visors for the University of Georgia’s Innovation Gateway In-
cubator. He is also a member of the Investor Advisory Board
for the Florida Institute for the Commercialization of Public
Research and serves as the Co-Chairman of the Innova-
tion Depot’s Funding Committee and is part of their Velocity
Program Committee. He is involved in the Venture Fellows
Program at the University of Alabama in Tuscaloosa and a
Visiting Executive in Residence at Auburn University.
VINOD DASA
Vice Chair, Academic Affairs, Department of Orthopedic Sur-
gery, LSU Health New Orleans
Vin Dasa (MD) is an Associate Professor, Vice Chair and Irvin
Cahen Chair of orthopedic surgery at LSU. He has helped
develop and deploy new health care technologies such as
iovera, and he was among the first surgeons to standard-
ize outpatient total knee replacements in the region. He has
helped create and develop new ideas and technologies
based on the changing health care paradigm.
GREGORY J. DAVENPORT
Vice President, The Conafay Group
Gregory J. Davenport (PhD) has more than 22 years of expe-
rience in medical product development and government con-
tracting. At The Conafay Group, he assists life-sciences and
biotechnology industry clients with strategic planning, cor-
porate development, and securing non-dilutive funding from
federal agencies. Prior to The Conafay Group, Dr. Davenport
was the executive vice-president and chief operating officer
of Logical Technical Services and chairman and co-founder
of Dport & Associates, LLC. Throughout his career, he has
held various C-level executive positions with private and pub-
licly-traded life-science companies. Dr. Davenport earned a
bachelor’s degree in biology from Dillard University, his doc-
torate in molecular biology from Howard University, and per-
formed post-doctoral studies at the University of Maryland
Medical Center and George Washington University Medical
Center. He serves on the board of LouisianaBio, the adviso-
ry board of the Mount Saint Mary’s University Biotechnolo-
gy & Management Program and the advisory council for the
Mount Opportunities for Success in Science.
MIKE ECKERT
Chairman, NO/LA Angel Network
Mike Eckert is a seasoned business executive with partic-
ular skills in start up businesses and early stage investing
and financing. Professionally he was a member of the launch
team of The Weather Channel and served as its President
and CEO for 14 years. He also served as Chairman and CEO
of Pathfire, a technology start-up which grew into a leading
digital asset management and distribution provider to me-
dia companies. Mike currently is actively engaged in various
facets of the early stage business and investing eco-sys-
tem: sitting on the Board of Directors of the national Angel
Capital Association, and as a member of its Public Policy
Committee; as Chairman of the NO/LA Angel Network, as
a member of the Investment Committee of the New Orleans
Start-Up Fund, as a member of the Board of Directors of
Nexus Louisiana, as a member of the LP Advisory Council of
the Louisiana Fund II, and as Executive Mentor of the incu-
bator cohort at Propeller. He also served as Chairman of the
Atlanta Technology Angels, leading the turn-around of a near

defunct angel group and building it into one of the major an-
gel investing groups in the US market; as a Fellow at Georgia
Tech’s VentureLab, on the Mentor-Steering-Committee at the
Advanced Technology Development Center in Atlanta, on the
Executive Committee of Start-Up Atlanta, and as Executive
in Residence at the Idea Village entrepreneur center.
PAULA ESTRADA DE MARTIN
Registered Patent Attorney, Baker, Donelson, Bearman, Cald-
well & Berkowitz, PC
Paula (PhD) is a life sciences and biotechnology patent attor-
ney in Baker Donelson's New Orleans office and is a member
of the Intellectual Property Group and the Global Business
Team. She focuses her practice on U.S. and foreign patent
prosecution for the life sciences, biotechnology and plant
fields; patent interferences; patent portfolio development and
management; patentability assessment; biosimilar assess-
ments and strategy; non-infringement and invalidity opinions;
due diligence; and pre-suit investigation and litigation sup-
port for life sciences and plant matters. Dr. Estrada de Martin
was formerly with WilmerHale in New York and was adjunct
faculty at New York Law School. Prior to joining WilmerHale,
She was a post-doc at Weill Medical College of Cornell Uni-
versity. In the summer of 1997, Dr. Estrada de Martin interned
at the NIH. From 1998 to 2004, she served as a teaching as-
sistant at Yale University while pursuing her doctoral studies.
KORY HALLETT
Program Manager, National Cancer Institute/SBIR Program
Kory is a Program Manager in the Small Business Innovation
Research Development Center at the National Cancer Insti-
tute. Kory manages program evaluation for the Center, and
provides program support in the areas of immunology, immu-
notherapy, and monoclonal antibody technology. She also
participates in the Center's many initiatives to support the
development of innovative cancer technologies. Kory joined
the NCI SBIR Development Center in 2014 as a Science &
Technology Policy Fellow with the American Association for
the Advancement of Science. Kory received her doctorate
in Cell and Molecular Biology in 2009 from the University of
Nevada, Reno. She completed a postdoctoral research fel-
lowship at the University of Wisconsin-Madison, where she
worked in a translational lab researching monoclonal anti-
body-based therapeutics for pediatric neuroblastoma.
JAMES HOBERG
Head of Licensing & External Innovation, MilliporeSigma
Jamie is currently Director of Business Development and
Licensing at EMD Millipore, responsible for identifying and
licensing new technologies in the life sciences area. Previ-
ously, Jamie was a Business Development Associate at the
Harvard Office of Technology Development. In this role Jamie
worked with university faculty in commercializing their inven-
tions. Jamie also had a brief stint at Quest Diagnostics in their
Athena Division as a Business Development Director. Jamie
has a PhD in Biochemistry from the University of Virginia.
PAMELA HORNBY
Senior Director and Fellow, Janssen R&D
Pamela is an accomplished Gastrointestinal and Translational
Pharmacologist with extensive experience in academia and
R&D. Her leadership resulted in the discovery and charac-
terization of eluxadoline (Viberzi), which is now a marketed
drug. She combines strong scientific acumen with an ability
to leverage global expertise and find creative funding sourc-
es to build scientific advances. She has received awards in
recognition of the impact of her work (100+ publications), is
Chair of the Translational and Clinical Pharmacology Division
of ASPET and has served on Advisory Review Boards.
RANDY HUBBELL
Randy is the President, CEO & Chairman of the Board for
Carmell Therapeutics, a biotech/medical device startup
company with a unique & highly innovative patented tech-
nology based on biologically-active materials manufactured
from human blood plasma. Prior to Carmell, Randy was Chief
Commercial Officer for Cardiva Medical, a start-up medical
device company focused on delivering technology to reduce
the complications associated with vascular access. Before
Cardiva, Randy was with Johnson & Johnson for 13 years
in various sales and marketing roles, most recently as VP
of Global Strategic Marketing at Ethicon Biosurgery. Before
moving to Ethicon, Randy worked in the J&J pharmaceutical
sector as the WWVP for Global Strategic Marketing for the
pain and cardiovascular therapeutic areas. Prior, Randy was
at Cordis Cardiology in 2001 as Director of Stent Marketing
and had responsibility for the launch of CYPHER in the US
market in 2003. In 2000, Randy had responsibility for sales
and marketing at Enmed, an Internet start-up with web-
based technology for conducting clinical trials. From 1998 to
2000, Randy was Executive Director of Sales and Marketing
for Vasca a start-up medical device company. Prior to Vasca,
Randy was in sales and marketing for Boston Scientific and
IBM. Randy received his MBA from Loyola University and his
BS from Tulane University.
MELI JAMES
Head of New Ventures, Sultan Ventures
Meli is the Head of New Ventures at Sultan Ventures, a bou-
tique venture firm focused on early-stage startups and in-
vestments; Program Director at the award winning XLR8UH,
a first of its kind venture accelerator formed in partnership
with the University of Hawaii; and President of the Hawaii
Venture Capital Association. She is a serial entrepreneur with
leading experience in mobile apps, web-based products and
community building. Prior to returning to her native Hono-
lulu, Meli lived in Silicon Valley for over 10 years, where she
co-founded and contributed to numerous start-ups in the
Bay Area and Honolulu, including Nirvino a #1 ranked wine
app, an Apple Platform Top 100 App, & Top Ten Lifestyles
App (during its time). Meli is an Entrepreneur in Residence
and alumna of Cornell University, and was recognized by En-
trepreneur Magazine as 1 of 5 “Women to Watch” in 2016.
ROY KELLER
Director, Louisiana Technology Transfer Office
Roy serves as the Associate Director of the Louisiana Busi-
ness and Technology Center, a high-tech small business
incubator on the campus of Louisiana State University. He

also serves as Director of the Louisiana Technology Transfer
Office, which operates throughout Louisiana and at offices at
NASA’s Stennis Space Center and the NASA Michoud As-
sembly Facility in New Orleans.
JOSEPH LOVETT
Mr. Lovett has over 34 years of venture capital and oper-
ations experience in the healthcare areas of biotechnology,
medical devices and equipment, diagnostics, imaging and
services. His operations experience included increasingly re-
sponsible positions in marketing and general management at
CR Bard, Mallinckrodt and Damon Biotech. His venture cap-
ital experience includes serving as general partner for three
venture capital funds (1988-2003) in affiliation with Harvard
University, managing $70,000,000 which resulted in thirteen
IPOs, six sales of private companies, and three private com-
panies. Mr. Lovett has a BA in economics from the University
of Vermont and an MBA from California State Polytechnic
University (Pomona).
BILL MASTERTON
President & CEO, University Medical Center New Orleans
Bill Masterton is President and Chief Executive Officer of Uni-
versity Medical Center New Orleans. He has more than 20
years of healthcare experience and an extensive background
in hospital operations and finance. Mr. Masterton previous-
ly served as CEO of Piedmont Medical Center in Rock Hill,
SC, as CEO of Coastal Carolina Hospital in Hardeeville, SC,
and as Chief Operating Officer and Chief Financial Officer in
Atlanta. Prior to that, Mr. Masterton worked in a number of
hospital financial roles. He began his health care career as a
consultant with KPMG. Mr. Masterton holds a Bachelor’s de-
gree in Accounting and a Master’s in Business Administration
from the University of Southern Florida.
ROBERT S. MUSCALUS
Medical Director, Care Transformation, Blue Cross and Blue
Shield of Louisiana
Dr. Rob Muscalus (DO) is the Medical Director for Care Trans-
formation at Blue Cross and Blue Shield of Louisiana (BCB-
SLA). In this capacity, he provides leadership and support
for the growth and development of BCBSLA’s ‘pay for value’
and shared savings programs. For the past 22 years, he has
held senior leadership and medical management positions in
the healthcare industry. He also served for six years in state
government as Pennsylvania’s Physician General, being an
advisor to the Governor and Secretary of Health on matters
pertaining to public health. Dr. Muscalus earned a degree in
Economics from the College of William and Mary where he
was also named a First Team Academic All American Foot-
ball Player. He is a graduate of the Philadelphia College of
Osteopathic Medicine and completed his training in Family
Medicine at the Geisinger Medical Center in Danville, PA.
CHARLIE PLAUCHE
Principal, S3 Ventures
Charlie Plauche is Principal at S3 Ventures. At S3, Charlie’s
responsibilities include sourcing and evaluating investments
in the technology and medical device sectors, performing
due diligence, and portfolio company management. Prior to
S3, Charlie was with Harbert Private Equity Funds, a subsid-
iary of Harbert Management Corporation. At Harbert, Charlie
analyzed and structured leveraged buyouts in the healthcare
and manufacturing sectors and assisted with portfolio man-
agement. He received his MBA from the McCombs School at
the University of Texas in Austin and his BS in Finance from
the University of Mississippi, where he was a Holmes Schol-
arship recipient and a Mississippi Eminent Scholar. Charlie
currently serves on the board of S3’s portfolio companies
Alkami Technology, Kimbia, Pristine, and Tango Health. In
addition, he serves as a board observer for TVA Medical, Or-
thoAccel Technologies, and Favor Delivery.
AIMEE M. QUIRK
CEO, innovationOchsner
Aimee Quirk is the CEO of innovationOchsner (iO), an inno-
vation lab and accelerator founded by Ochsner Health Sys-
tem in 2015 to reimagine and revolutionize the experience
and delivery of healthcare in a way that creates new value
by enhancing quality, affordability and access. Aimee joined
Ochsner in 2015 with more than 15 years of experience in
law, economic development and public affairs. She served
for over four years as the Senior Advisor for Economic Devel-
opment in the Office of New Orleans Mayor Mitch Landrieu.
Prior to her public service, Aimee was a partner at Jones
Walker, where she practiced corporate and business litiga-
tion. Aimee received her JD from Tulane University and her
BS in Finance from Louisiana State University. A native of
New Orleans, she is active in the community and serves on
several nonprofit boards.
RACHEL RIMSKY
Associate Director, Research Partnerships, The Michael J. Fox
Foundation for Parkinson's Research
Rachel Rimsky manages MJFF’s industry strategy, whose
objective is to de-risk investments in Parkinson’s research
and accelerate as many therapeutics as possible into clinical
trials. MJFF’s industry approach integrates the Foundation’s
research investments with structured collaborations across
partners in large pharma, research organizations, biotechs
and venture capital. MJFF aims to create an efficient pathway
for disease research. Before joining MJFF, Rachel was a Vice
President in the Alternative Investments & Manager Selec-
tion division at Goldman Sachs, where she was responsible
for hedge fund investment diligence. Rachel graduated from
Cornell University with a BS in Industrial & Labor Relations.
CIAN C. ROBINSON
Cian Robinson is Executive Director of the Lafayette General
Foundation. He is also an adjunct instructor at B. I. Moody
School of Business at the University of Louisiana at Lafay-
ette. Cian earned his Bachelor’s in Mathematics at St. Vin-
cent College as well as a Master’s in Management and Policy
at Carnegie Mellon University. He is currently pursuing his
Doctorate in Leadership at ULL. Prior to the Lafayette Gen-
eral Foundation, Cian had a 20 year career as a management
and information technology consultant with his own firm,
Robinson Ventures.

KORAK SARKAR
Neurologist, Ochsner Health System
Korak is a neurologist with a speciality in Brain Injury Medicine
and Rehabilitation and a focus on traumatic brain injuries. In
addition to his clinical interests, he has a strong interest in
bio-innovation. He participated in a post-doctoral biodesign
program at Northwestern University and has pursued this in-
terest in New Orleans at Ochsner, NOBIC, and Tulane. He is
particularly interested in the role of digital health in facilitating
the transition from a fee for service to a value-based health
care system.
JOSEPH SIMEONE
Director, Business Development & Licensing, Merck
Joe (PhD) is currently a Director within the Business Devel-
opment and Licensing department of Merck Research Labs.
His current focus is on the search and evaluation of enabling
technologies. Prior to the S&E role, he was responsible for
transacting discovery focused business deals and he also
had a long and productive career as a laboratory scientist.
Joe earned MS and Ph.D. degrees in Organic Chemistry
from Seton Hall University.
HOPE SHIMABUKU
Director, U.S. Patent and Trademark Office Texas Regional Office
As the Director of the Texas Regional United States Patent
and Trademark Office (USPTO), Hope Shimabuku carries out
the strategic direction of the Under Secretary of Commerce
for Intellectual Property and Director of the USPTO, and is
responsible for leading the Texas regional office, focusing
on the region and actively engaging with the community.
Ms. Shimabuku has nearly two decades of experience as
an engineer and intellectual property attorney. Most recently,
Ms. Shimabuku was part of the Office of General Counsel
at Xerox Corporation serving as Vice President and Corpo-
rate Counsel responsible for all intellectual property matters
for Xerox Business Services. Ms. Shimabuku is a leader in
the Texas region, currently serving as the Chair for the State
Bar of Texas Intellectual Property Section. Ms. Shimabuku
received a BS in Mechanical Engineering from the University
of Texas at Austin, and graduated cum laude with a JD from
the Southern Methodist University Dedman School of Law.
ROBERT R. TUCCI
Rob Tucci is a private investor, entrepreneur, and ten year
member of the Houston Angel Network where he is Chair,
Life Sciences. He is Co-Founder of Houston Health Ven-
tures, a life science-focused fund affiliated with the University
of Houston. Rob is a Managing Director and investor-mem-
ber of the Texas Halo Fund where he generally focuses on
opportunities in the life sciences. He is a regular speaker
on life science and angel investing, participating in events
at Jlabs, RESI, BioHouston, Greater Houston Partnership,
National Biomedical Research Institute, Rice Business Plan
Competition, TMCx, Red Labs, Owl Spark, HTC, University
of Houston Cougar Fund, i2E/Governor’s Cup (Oklahoma),
University of Texas, Texas Tech University, TiE, Society of
Physician Entrepreneurs, University of St. Thomas, and The
BioInnovation Center. Rob is a chemist/MBA and a board
member/observer at Adient Medical, Materna Medical and
Quad Technologies.
WILLIAM WILKISON
William Wilkison (PhD) is the Chief Scientific Officer and
founder of Avolynt, Inc., a clinical stage pharmaceutical com-
pany focused on developing novel therapeutics for metabolic
diseases. Prior to founding Avolynt, Dr. Wilkison spent sever-
al years at GlaxoSmithKline in business development manag-
ing key relationships between GSK and partner companies.
Prior to GSK, Dr. Wilkison was a founder and Chief Operat-
ing Officer at Artecel Sciences, Inc. a stem cell development
company, which was spun off from Zen-Bio, Inc. another
biotech company founded by Dr. Wilkison, focused on the
development and commercialization of human adipose cells.
Dr. Wilkison spent six years at Glaxo/GlaxoWellcome study-
ing metabolic disease and was responsible for target/lead
identification and development. Dr. Wilkison has published
numerous peer-reviewed manuscripts and is an inventor on
several issued patents. He holds a PhD from Duke University
and did his postdoctoral work at Harvard Medical School.
BRETT WINGEIER
Co-founder and Chief Technical Officer, Halo Neuroscience
Brett Wingeier, PhD, is CTO and co-founder of Halo Neuro-
science, a venture-backed startup in San Francisco, and is
responsible for engineering and technological development.
His role at Halo builds on twenty years of experience cre-
ating innovative, reliable, science-based products that push
the limits of possibility and make a difference in human lives.
Prior to co-founding Halo, Brett was principal engineer and
clinical scientist at NeuroPace, bringing to market the world's
first fully-implantable responsive neurostimulator for epilepsy.
Previously, he was also instrumental in designing Autonomic
Technologies' Pulsante, the world's first minimally-invasive,
implanted stimulator for headache, and has consulted ex-
tensively on high-reliability systems and data science. With
a doctorate in biomedical engineering from Tulane, focusing
on electric fields in the brain, Brett has published academ-
ic research in the areas of EEG, electrophysiology, and the
electrode-tissue interface. He is also a US registered patent
agent and holds over thirty issued US patents.
ADAM ZERDA
Adam Zerda is Senior Manager for Strategic Innovation and
Business Development at BD. Based at BD Technologies in
Research Triangle Park, NC, he is responsible for develop-
ment of world-wide growth opportunity assessments related
to business, segment and corporate needs and strategic in-
terests while working with BD's strategic and external part-
ners. Since joining BD in 2007 as a Staff Engineer, Adam has
held roles of increasing responsibility within both the Market-
ing and R&D organizations. Prior to BD, Adam was a Lead
Scientist at GE Plastics with increasing level of responsibility
during his five year tenure. Adam completed a BS in Chem-
istry from Texas Christian University and an MS and PhD in
Polymer Science & Engineering from University of Massachu-
setts at Amherst.

Accelerator: An organization dedicated to jumpstarting start-
up companies through intensive, months-long programs.
Accredited Investor: An individual or entity in the US that
meets set legal qualifications. An individual is an accredited
investor if one has a net worth of at least $1 million, individu-
ally or jointly with one’s spouse, excluding the value of one’s
residence, or has an annual income of at least $200,000 in-
dividually or $300,000 jointly with one’s spouse. An individual
who is a registered broker or investment advisor is also an
accredited investor.
Angel Investor: An affluent individual who invests capital in a
startup’s early stages. Not all angels are accredited investors.
CE (Conformité Européene) Marking: A mandatory conformity
marking for certain products sold within the European Eco-
nomic Area (EEA). Medical devices and diagnostics must ob-
tain a CE marking to sell in the EEA.
Centers for Medicare and Medicaid Services (CMS): The agency
that oversees numerous federal healthcare programs.
Commercialization: The process of introducing a new product
or service to the market.
Contract Research Organization (CRO): A service provider that
supports activities such as preclinical research, assay devel-
opment, clinical trials, and pharmacovigilance. CROs range
from large, full-service companies to smaller, niche specialty
groups.
Convertible Note: A form of short-term debt that converts into
equity, typically in conjunction with a future financing round.
De Novo Classification: An alternate pathway to PMA for de-
vices of low to moderate risk that fall into Class III solely be-
cause no substantially equivalent device exists. Scientific
and clinical evidence of safety and effectiveness is typically
necessary, but the requirements are much less stringent than
those for PMA.
Dilution: A reduction in the existing owners’ equity or owner-
ship percentages in proportion to the amount the investor will
own after an investment. Example: Startup A is owned by the
founders and angel investors. The founders own 80% of the
company, and angel investors own 20%. When the Series A
investors invest, they receive 20% of the company for their
investment. The founders will now own 64% of the company,
the angel investors will own 16%, and the Series A investors
will own 20%.
Due Diligence: Comprehensive process that prospective in-
vestors carry out to evaluate a startup’s commercial potential.
Employee Pool (Option Pool): An employee compensation sys-
tem used to reward early startup staff. The employee pool
is a set amount of company equity that can be awarded to
employees, often instead of paying a higher salary. The em-
ployee pool is often referred to as an option pool because
the equity is granted in the form of options for tax purposes.
Exit: An event where an outside party acquires all or a signif-
icant portion of a startup’s equity, providing cash liquidity to
the equity owners. Examples of exits include acquisitions by
larger companies, licensing agreements, and IPOs.
Food and Drug Administration (FDA): The US government agen-
cy responsible for assuring the safety, efficacy, and security
of human and veterinary drugs, biological products, medical
devices, foods, cosmetics, and products that emit radiation,
as well as regulating the manufacturing, marketing, and dis-
tribution of the previously mentioned products.
Founder/Co-Founder: A person involved with the initial launch
of the company, who may not be the inventor of the tech-
nology.
Health Insurance Portability and Accountability Act (HIPAA): US
law that provides data privacy and security provisions for
safeguarding medical information, including requirements for
the protection and confidential handling of protected health
information, and mandates for industry-wide standards of
healthcare information on electronic billing and other pro-
cesses.
Incubator: An organization dedicated to helping startup com-
panies develop by providing services, such as training, men-
toring, workspaces, and seed funding. An incubator does
not generally have a set time limit for its services.
Institutional Review Board (IRB): A committee formally desig-
nated to approve, monitor, and review biomedical and behav-
ioral research involving humans. An IRB can be independent
or affiliated with another organization, such as a university
or hospital. The purpose of an IRB is to assure appropriate
actions are taken to protect the rights and welfare of study
participants. The Institutional Animal Care and Use Commit-
tee (IACUC) is the equivalent committee for animal research.
Investigational Device Exemption (IDE): A permission from the
FDA that allows an investigational device to be used in a clin-
ical study to collect safety and effectiveness data.
Investigational New Drug (IND) Application: A request for autho-
rization from the FDA to administer an investigational drug or
biological product to humans.
License Agreement: Provides the right to commercially use IP
and spells out the financial and legal terms of that use.
Limited Liability Company (LLC): A simplistic US business
structure that combines the pass-through taxation of a part-
nership/sole proprietorship with the limited liability and pro-
tection of personal assets of a corporation. An LLC is typical-
ly the first form of a startup; it can be easily converted into a
C corporation or other business formation.
New Drug Application (NDA): A formal proposal that the FDA
approve a new pharmaceutical for sale and marketing in the
Commercialization Glossary

US. The NDA requires the company to submit enough data
gathered through animal studies and human clinical trials to
permit the FDA to determine the drug is safe and effective
for the proposed uses, the benefits outweigh the risks, the
proposed labeling is appropriate, and the manufacturing and
controls are adequate. Abbreviated requirements are out-
lined for less risky new drugs.
Nonprovisional Patent Application: A legal document filed with
the United States Patent and Trademark Office (USPTO) to
request a utility patent to protect an invention. A nonprovi-
sional patent application must include a specification, includ-
ing a detailed description and a claim or claims; drawings;
an oath or declaration; and the prescribed filing, search, and
examination fees. The claims are what define the scope of
the protection of the patent.
Operating Agreement: An agreement among members of an
LLC governing the business, including the members’ finan-
cial and managerial rights and duties.
Option Agreement: A document that provides a company a
time-limited right to obtain a full license agreement by “exer-
cising” the option to obtain the license. An option agreement
is typically used when a company wants to do further re-
search and development to evaluate the technology prior to
entering into a full license agreement. An option agreement
does not allow the company to commercially market and sell
the technology.
Orphan Drug Designation: An FDA classification that provides
benefits, such as an expedited path to market and a peri-
od of exclusivity, to pharmaceutical companies developing a
drug intended to treat a rare disease or condition.
PCT/International Patent Application: A legal document filed un-
der the Patent Cooperation Treaty (PCT), a patent law trea-
ty that includes 153 countries, which begins the process of
seeking patent protection in any of the member countries. An
international patent application serves as a single application
in all member countries but does not mature into an interna-
tional patent; instead, individual, national patent applications
must be filed within 30 months of the patent priority date.
Premarket Approval (PMA): The FDA process to evaluate the
safety and effectiveness of Class III medical devices. Class
III devices are those that support or sustain human life, are
of substantial importance in preventing impairment of human
health, or which present a potential, unreasonable risk of ill-
ness of injury. PMA carries the most stringent FDA require-
ments.
Premarket Notification [PMN or 510(k)]: A premarket submis-
sion made to the FDA to demonstrate that a new device is
at least as safe and effective (i.e. substantially equivalent) as
a legally marketed device that is not by definition subject to
PMA. A 510(k) is typically the fastest and easiest route to
market.
Provisional Patent Application: A legal document filed with the
USPTO that establishes an early filing date for an invention.
The USPTO does not perform an examination of the patent-
ability of a provisional patent application. A provisional patent
application does not mature into an issued utility patent; a
nonprovisional patent application or international patent ap-
plication (PCT) must be filed within one year.
Reimbursement: The amount the insurance company pays
the healthcare provider for services.
Seed Capital: Initial funding raised to support preliminary ac-
tivities, including early product and business development.
Series A: The name typically used to describe a startup’s first
significant round of venture capital financing. Subsequent
rounds of funding are referred to as Series B, Series C, and
so on.
Small Business Innovation Research (SBIR) and Small Business
Technology Transfer (STTR) Grants: Federal grants available to
small businesses to research the technological potential for
commercialization of new innovations. SBIR and STTR grants
are structured in three phases of increasing value based on
technology readiness. SBIR and STTR grants differ in PI and
research partner stipulations.
Startup: A business that is typically technology-oriented and
has high growth potential and a foreseeable exit.
Term Sheet: A document outlining the terms by which an in-
vestor will make a financial investment in the company.
Trademark: A word, phrase, symbol, or design, or a combi-
nation thereof, that identifies and distinguishes the source of
the goods of one party from those of others. A trademark can
be filed with an intent to use or following use in commerce.
Registering a trademark is not necessary but provides many
benefits, such as the ability to sue in federal court, the ability
to register for incontestability, official notice of the registra-
tion, and the ability to use US Customs to stop imports of
infringing goods.
Utility Patent: A patent issued for the invention of a new and
useful process, machine, manufacture, or composition of
matter, or a new and useful improvement thereof. A utility
patent generally excludes others from making, using, or sell-
ing the invention for a period of 20 years from its application
filing date.
Valuation: The current worth of a company. There is no single
way to determine a valuation; analysts tend to look at the
company’s management, capital structure, current market
value, IP, and prospective earnings. Pre-money valuation is
the worth of the company before the investment; post-mon-
ey valuation is the worth of the company after the investment.
Venture Capital: Financing that investors provide to startups
with long-term growth potential in exchange for equity. Ven-
ture capital is usually invested through funds that have their
own investors. Venture capital funds often expect to see a
return on investment within a specific timeframe to pay its
investors.
Vesting: The process by which founders and employees earn
their equity grants over time. Investors usually require vesting
instead of employees receiving all equity at once to ensure
commitment. A common vesting timeline is for the employee
to receive 25% of their stock grant after one year, and the
remaining 75% monthly for the next three years.

Global Entrepreneurship Week is an annual worldwide
celebration of the innovators and job creators who launch
startups that bring ideas to life, drive economic growth, and
expand human welfare. GEW inspires people everywhere
through events that connect entrepreneurs, potential partners,
mentors, and investors. GEW is a platform for connection and
collaboration—engaging all players on the entrepreneurship
spectrum in strengthening ecosystems around the world.
www.neworleansbio.com

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