How should a scientist with an exciting idea begin his or her search for government funding opportunities? What advice can experts offer on drafting an impactful proposal? What is the expectation of the role of innovation in large government programs?
The distinguished panelists for this webinar are:
Dr. Cheryl Martin, Deputy Director for Commercialization, Advanced Research Projects Agency – Energy (ARPA-E)
Dr. Cheryl Martin is currently the Deputy Director for Commercialization for the Advanced Research Projects Agency – Energy (ARPA-E), responsible for leading the organization’s commercialization program to help breakthrough energy technologies succeed in the marketplace. Prior to this, Dr. Martin was an Executive in Residence with Kleiner Perkins Caufield and Byers, a venture capital firm based in Menlo Park, California. Previously, she was with Rohm and Haas Company for 20 years and served in many capacities including Corporate VP.
Dr. Martin earned a B.A. degree in Chemistry from the College of the Holy Cross. She went on to earn a Ph.D. in Organic Chemistry from the Massachusetts Institute of Technology (MIT). She is active in the American Chemical Society (ACS) at both the local and national levels and serves on the Board of Directors for Philabundance, the greater Philadelphia region’s largest hunger relief organization.
Dr. Ben Schrag, Program Director, National Science Foundation (NSF)
Dr. Ben Schrag is currently the cluster lead for Nanotechnology, Advanced Materials, and Manufacturing in the Small Business Innovation Research (SBIR) program at the NSF. He joined the NSF as an SBIR Program Director in 2009. Prior to this, he worked for six years as Director of Research and Development at a start-up company, Micro Magnetics, where he led a development effort to commercialize a new family of high-performance magnetic microsensor products as well as a magnetic diagnostic system for failure analysis and fault isolation in semiconductor devices.
Ben has served as a visiting scientist at Brown University and as the Principal Investigator on a number of federal grants and contracts, including NSF Phase I and Phase II Small Business Innovation Research projects and an Advanced Technology Program award from NIST. He received his Ph.D. in Physics from Brown University in 2003.
Dr. Judith Giordan, Partner in ecosVC and Senior Advisor to the National Collegiate Inventors and Innovators Alliance (NCIIA), moderates the panel.
In a career that has spanned 30 years, Dr. Giordan, the recipient of the 2010 Francis Garvin-John Olin medal of the American Chemical Society, has served in executive and leadership positions in R&D and operations at some of the world's top brands, including International Flavors and Fragrances, Inc., the Pepsi-Cola Company, and the Henkel Corporation.
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October 10, 2012 | 2:00-3:30pm ET
Marcus Nanotechnology Building | Room 116
The demand for personalized care, greater cost-savings, flexibility, interactivity, and portability in health delivery systems, records management, and treatment are driving innovation. The sheer number, variety and complexity of products that have been, and are being developed have led the Food and Drug Administration, Federal Communications Commission, Centers for Medicare and Medicaid Services and other regulators to issue new regulations, guidelines, and approvals.
The convergence of wireless and medical technologies is changing the way consumers and healthcare providers manage health and treat disease. Pharmaceutical and medical device manufacturers, insurers, software developers, and physicians are partnering with network providers to offer Health IT solutions to provide greater flexibility, connectivity, and interoperability in the delivery of health care, health education, and patient self-care services. The number of health and wellness apps, clinical decision support technology, and other integrated diagnostic devices on the market has increased exponentially in the past year.
Join us for this Free interactive panel with some of the industry’s top experts to help guide you through the regulatory landscape for Mobile Apps and Clinical Decision Support Technology.
Your regulatory experts Vernessa Pollard, Allison Shuren, Maureen Jeffreys and Nancy Perkins of Arnold & Porter LLP will explain how many of these products and solutions are currently regulated by the FDA, FCC, CMS, the Health and Human Services Department’s Office of the Inspector General and Office for Civil Rights, and others, and the new legal and regulatory challenges they present for industry and regulators. This webinar will provide you with:
Vernessa Pollard is a partner in Arnold & Porter LLP's FDA and Healthcare group, principally focusing on regulatory matters involving the US Food and Drug Administration and US Department of Justice (DOJ). She advises companies on regulatory, compliance, enforcement, and legislative matters involving pharmaceuticals, medical devices, cosmetics, food, and medical technology and software. She regularly counsels companies on product approvals, Good Manufacturing Practice (GMP) and Quality System (QS) requirements, advertising and promotion, adverse event reporting, FDA Warning Letters, FDA inspections, recalls, import detentions, and corporate compliance programs. She has represented companies and executives in FDA and DOJ investigations and enforcement matters. The National Law Journal named her one of the 2011 Minority 40 under 40.
Allison Shuren is a partner in the FDA/Healthcare group of Arnold & Porter LLP. Her practice focuses on healthcare regulatory issues, including fraud and abuse counseling and investigations involving allegations under the False Claims Act, Anti-Kickback Statute, and the Stark Law; implementation and audit of corporate compliance programs and government imposed corporate integrity agreements; counseling regarding joint ventures and complex contractual arrangements with referral sources; and assisting clients launching innovative technologies navigate the complex coding, coverage, and payment landscape. Ms. Shuren has been ranked in Chambers USA: America's Leading Lawyers for Business since 2007 and recently named a Life Science Star in LMG Life Sciences 2012.
Maureen Jeffreys is a partner in the Telecommunications, Internet and Media group of Arnold & Porter LLP. She provides regulatory, compliance, enforcement, transactional, and litigation counseling to wireline, wireless, cable television, media, and Internet clients. She represents these clients before the Federal Communications Commission (FCC), the National Telecommunications and Information Administration (NTIA), and elsewhere. Ms. Jeffreys regularly counsels clients regarding the regulatory implications of emerging trends in the communications ecosystem, including recent developments in mobile health.
Nancy L. Perkins, counsel in the Data Privacy and Security group of Arnold & Porter LLP, has an extensive practice in the regulation of privacy and security of personal information. She has particular expertise with the privacy, security, breach notification, and enforcement regulations implementing the Health Insurance Portability and Accountability Act (HIPAA), the Health Information Technology for Economic and Clinical Health (HITECH) Act, and the emerging body of regulatory actions governing data privacy and security with respect to mobile applications. Nancy has been ranked consistently by Chambers USA as a “Leading Individual” for Privacy & Data Security and has published numerous articles in the area, including "Expanded Liability For Health Data Uses and Disclosures: What New Risks Loom Under the Proposed Privacy and Security Rules Implementing the HITECH Act?" Bloomberg's Privacy & Information Law Report, Vol. 3, No. 9, September 2010, and "Proposed U.S. HITECH Act Data Privacy And Security Rules: How Would They Impact Pharmaceutical Companies?" BNA Privacy & Security Law Report, Pharmaceutical Law & Industry Report, and International's World Data Protection Report. August 2010.
Please join us for what should be an informative session.
]]>Workshop Description
This workshop will bring FDA internal experts together with academic and industry stakeholders to discuss challenges and approaches in defining minimum clinically important difference (MCID) for patient-reported outcome (PRO) instruments used in orthopaedic device-related procedures. The goal is to streamline evidence-based scientific rationales for regulatory guidance of clinical trials and device study design for gender, age and BMI factors.
Who Should Attend?
Orthopaedic device companies focusing on upper and lower extremities, regulatory affairs, clinical evaluators, product developers, project managers, contract research organizations and academic researchers and industry stakeholders responsible for designing, implementing, analyzing and reviewing MCID for orthopaedic device clinical studies. FDA participants expected to participate come from the following areas: CDRH, ODE, OJDB, OSB, OWH, and AHRQ.
What to Expect?
This one and a half day meeting will include presentations by the FDA, industry participants, and academia on day one. Breakout sessions on day two will develop and present feedback in specific clinical areas from experts in the field concerning the appropriate methodology and strategy to launch future work and guidance.
Aren't available to attend in person?
This public workshop will also be available as a Webcast for registrants only. Persons interested in viewing the Webcast must register online at the TRIBES Website by November 19, 2012. Early registration is recommended because Webcast connections are limited. Organizations are requested to register all participants, but to view using one connection per location. Webcast participants will be sent technical system requirements after registration and will be sent connection access information after November 19, 2012.
Participating Companies:
SEMDA
GT TRIBES
APDC
ATDC
GT BioID
RAPS
GaBIO
AICC
Ga PDMA
ACTSI
GCMI
ASQ
Ga HIMSS
Emory OTT
MACOC BLC
TAG Health
Cost: $10.00
Cash Bar and snacks available
Hosted by:
200 Office (formerly the historic downtown Macy’s building)
Discounted Self parking:
150 Carnegie Way
Directions and parking details are here.
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Come learn about the new Atlanta Pediatric Device Consortium and/or participate in the competition. Please RSVP at http://pediatricdevicesatlanta.org/competition. The Pediatric Device Competition will provide a competitive opportunity for the Atlanta scientific and business community (scientists, clinicians, faculty, investigators, researchers, clinical residents/fellows, medical, graduate and undergraduate students, and entrepreneurs) to develop a pediatric medical device concept benefitting from the expertise and infrastructure of the APDC.
Awards from $5,000 to $50,000 will be made depending on the complexity of the device and its development stage. APDC made 6 project awards in 2011. More information at http://pediatricdevicesatlanta.org/competition
]]>A one-and-a-half day "how-to" course for inventors, surgeons, clinicians and other healthcare providers interested in learning essential steps in developing ideas for new and improved medical products and techniques.
Topics include:
CME Credits:
This activity has been planned and implemented in accordance with the Essential Areas and policies of the Medical Association of Georgia (MAG) through the joint sponsorship of Children’s Healthcare of Atlanta and Georgia Tech Translational Research Institute for Biomedical Engineering and Science.
Children's Healthcare of Atlanta is accredited by the Medical Association of Georgia to provide continuing education for physicians.
Children's designates this live activity for a maximum of 7.5 AMA PRA Category 1 credits TM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Please visit our website for updates: www.tribes.gatech.edu/bioidconf2013
]]>Biomedical Innovation and Development Conference - A "how-to" course for inventors, surgeons, clinicians and other healthcare providers interested in learning essential steps in developing ideas for new and improved medical products and techniques.
]]>Office:404-385-4363
]]>Join your regulatory colleagues from across the Atlanta area for an afternoon of networking and to hear presentations and a panel discussion entitled, “Understanding Regulatory Requirements for Human Factors Usability Testing.” This program will provide attendees with an expert overview of FDA’s latest draft guidance and to ensure that you are up to date on all the new requirements. This meeting is sponsored by the RAPS Atlanta Chapter to promote knowledge advancement and facilitate networking among local regulatory professionals.
The panelists for this virtual program will be presenting from all over the country. But participants at this Atlanta Chapter event will hear the presentation of Maria Shepherd, MBA live and in-person.
The guidance, released on 22 June, 2011, stated that, as part of design control, medical products manufacturers must conduct a risk analysis to assess and mitigate risks associated with device use. If you are a device manufacturer you should be performing appropriate human factors engineering and usability testing.
This program will cover all new requirements, including:
View the Program Agenda for a more detailed description of each presentation.
Program Chair and Moderator:
Penny Northcutt, RAC, FRAPS, CQA, REGSolutions LLC, a company that provides regulatory solutions and quality systems for the life science industry.
Panelists:
Maria Shepherd, MBA, Data Decision Group, a company providing human factors engineering usability testing to the medical products industry.
Kathleen Whanger, MS, senior quality engineer at Boston Scientific working on the human factors engineering corporate team.
Molly Follette Story, PhD, a human factors and accessible medical technology specialist, one of three full‐time human factors reviewers in the Center for Devices and Radiological Health, Office of Device Evaluation, FDA.
Please join us on Friday, June 1st from 7:30AM-1:00PM for a half-day seminar showcasing on-going pediatric research projects from the Atlanta community.
All faculty, students, residents and fellows are invited to submit an abstract by May 7th for and oral and/or poster presentation. All abstracts will be reviewed and only 12 oral presentations will be selected. We are interested in both clinical and translational research projects.
Cash prizes will be awarded for the best oral and poster presentation!
KEYNOTE SPEAKER
Robert M. Campbell, M.D.
Professor of Orthopaedic Surgery
Children’s Hospital of Philadelphia
Robert M. Campbell Jr., M.D., is a pediatric orthopedist esteemed for his role in inventing the Vertical Expandable Prosthetic Titanium Rib (VEPTR). VEPTR is used to treat rare diseases of the spine and chest wall, through surgical expansion of the chest and correction of spinal deformity, without inhibiting children’s growth. The titanium rib, approved by the FDA in 2004, has been introduced in more than 30 countries and is considered the gold standard for treating fragile pediatric patients with lung-restricting deformities. He has also published extensively on the thoracic and pulmonary disability of these patients and was the first to identify the disease Thoracic Insufficiency Syndrome (TIS).
404-385-0247
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During our April 19 chapter meeting, the graduate and undergraduate winners of the 2012 Student Award program will present their entries and receive their $1,500 and $1,000 top prizes.
This exciting annual event is a great chance to engage with the next generation of service and product developers. If you're a student, you'll see what your classmates - and the competition are doing. As a NPD professional, your experience and insights will help these students refine the skills that they'll need as they enter the business world. You might also meet yournext employee or intern!
Kicking off our event will be Franklin Bost, Professor of the Practice, Wallace H. Coulter Department of Biomedical Engineering, Georgia Institute of Technology and Emory University, Georgia. In addition to academic responsibilities, Mr. Bost is also the CEO of SpherIngenics, Inc., a Georgia Research Alliance VentureLab funded campany, focused on commercializing technologies and products for precise delivery of stem cell based products.
EVENT DETAILS:
Cost:
Non-PDMA members: $25
PDMA members: $20
Summit Season Pass Holders: Free! (use Priority Code on card)
Students w/ID: Free! (Use Priority Code STUDENT12)
Location:
Georgia Tech, Parker H. Petit Institute of Bioengineering and Bioscience (IBB),
Atrium and Suddath Conference Room
315 Ferst Drive NW
Atlanta GA, 30332
Registration is required.Click here to register.
]]>Agenda:
12:00-12:30pm – Registration and Lunch
Key Speakers
12:30-1:35pm
1:35-1:50pm – Barbara Boyan – 2011 Success
Previous Seed Grants RecipientSpeakers
1:50-2:20pm
2:20-2:40pm – BREAK
Point of Care technologies/devices
2:40-3:00pm – Overview and Pediatrics Point of Care – Wilbur Lam
3:00-3:15pm – Emergency Point-of-Care – Jeremy Ackerman
3:15-3:30pm – TBI Point of Care – Michelle LaPlaca / Chris Ward
3:30-3:45pm – Wound Healing/Bleeding Point of Care – Andrew Lyon/ Thomas Barker
3:45-4:15pm – Discussions and New Initiatives
4:15-5:00pm – Networking
]]>Come meet other bioengineering investigators and initiate new collaborations.
Meeting Topic: Point-of-Care Technologies.
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Hosted by the Atlanta Pediatric Device Consortium (APDC), the event will give out three to five awards ranging from $25,000 to $50,000 depending on the device and its stage of development. Devices will be targeted to the pediatric population and divided into four age groups, ranging from birth to age 21. Submissions will come from faculty, entrepreneurs, clinicians, fellows, residents and students from any of the APDC institutions (consisting of Georgia Tech, Emory University, Saint Joseph Translation Research Institute and Children’s Healthcare of Atlanta).
APDC was launched this month with a two-year, $1.8 million grant from the Food and Drug Administration (FDA) to encourage the development of medical devices tailored to the needs of children, with the plan of taking the devices from conception to commercialization.
RSVP to the event online.
]]>Agenda
8:00 am BREAKFAST
8:30 am Welcome and GT/IBB Overview - Robert Guldberg
8:45 am GTRI Overview - Jeff Evans
9:00 am TRIBES - Barbara Boyan
Session 1 - Chair: Shean Phelps, Co-Chair: Ravi Bellamkonda
9:20 am - Human Factors (ELSYS) - Brad Fain
9:40 am - Outcomes Research - Beth Mynatt
10:00 am - Information and Communications Lab (ICL) - Margaret Loper
10:20 am - COFFEE BREAK
Session 2 - Chair: Andres Garcia, Co-Chair: Ralph Herkert
10:40 am - Sensors and Testing (EOSL) - Gisele Bennett
11:00 am - Nanomedicine - Gang Bao
11:20 am - Capstone Design - Franklin Bost
11:40 am - LUNCH BREAK – NETWORKING
Session 3 - Chair: Barbara Boyan, Co-Chair: Jeff Evans
1:00 pm - Robotics (ATAS) - Gary McMurray
1:20 pm - Healthcare Robotics - Charlie Kemp
1:40 pm - Sensors (STL) - Jim Acree
2:00 pm - BREAK
Session 4 - Chair: Leanne West, Co-Chair: Michelle LaPlaca
2:20 pm - Drug Design Development and Delivery - Mark Prausnitz
2:40 pm - Imaging and Signaling Processing (SEAL) - Kristin Bing
3:00 pm - Innovative Cardiovascular Technologies - Ajit Yoganathan
3:20 pm - Group Discussion and Plan of Action
4:00 pm - Adjourn