What Lies Ahead for 2013?

DIA's first annual What Lies Ahead? report, provides expert insight into the year ahead for pharmaceuticals, biotechnology, and the product development of medical devices.

With thought leaders from industry and academia asked to choose the trends they foresee shaping the world of medical product development in 2013 most agreed that the number one trend for this year will be “new models of innovation.” Based on the report, it is highly anticipated that industry will focus on collaboration and partnerships which are becoming the new norm for therapeutic research and development as companies look to capitalize on innovations outside their own walls. The report points to shrinking industry R&D budgets as being a motivator for such partnerships. The desire to reduce the time to market for urgently needed medicines and to avoid needlessly exposing patients to previously failed approaches were highlighted as strong motivators as well.

Susan Cantrell, Director, North America at DIA said, “We are excited to provide insights into where the industry is heading each year and what may continue to grow in importance over the next few years. These projections of the future landscape can be valuable to companies as they strategize to successfully meet the ever-changing needs of the marketplace.”

The study shows expectations of 2013 are that of the continued strengthening of consumer/patient empowerment (2^nd most expected trend), a focus on unmet medical needs as the driver for innovations, and growing regulatory cooperation and convergence across multiple regions.

“While this study is specific to North America, and the United States in particular, as the global forum for therapeutic innovation and regulatory science we anticipate it being useful on a worldwide scale,” said Cantrell.

Therapeutic Innovation & Regulatory Science in 2013

1. New Models of Innovation.

2. The Continued Rise of Patient/Consumer Empowerment: the Importance of Patient/Consumer Engagement.

3. Learning How to Utilize Big Data.

4. Achieving Market Access is the New Goal, and Value Is a Key Driver.

5. Regulatory Cooperation and Convergence.

6. Personalized Medicine/Tailored Therapies and Companion Diagnostics.

7. An Explosion of Mobile Health Applications.

8. Continued Importance of Global Markets.*

9. Clinical Trial Data Transparency.*

10. Growing Ability to Make Meaningful Benefit–Risk Assessments.*

11. Laser Focus on Unmet Medical Needs.*

*Trends 8-11 each received the same number of votes for inclusion in the “Top 10” trends.

12. The Era of Data Standardization Is Here.

To obtain a copy of the study or to interview a respondent, please contact Eric Rosen at Eric.Rosen@diahome.org or at +1.215.290-9153.
- See more at: http://www.diahome.org/en/News-and-Publications/Newsroom/What-Lies-Ahead-in-2013.aspx?_id=DDD6EB0B232743E691EF5C3AE65D9F42&_z=z#sthash.MK9eJL9M.dpuf

DIA2012 - 49th Annual Meeting, June 24-28, Philadelphia

Wendy Kovitz 4 Days. 22 Tracks. 500+ Exhibitors. 7,500+ Attendees. Join more than 7,500 professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices, and related products to unlock the innovation needed to expand global access to effective and affordable patient care. Register Online or Download Registration Form by May 18 to be Included on the Advance Attendee List! DIA 2012 Mobile Apps Now Available on Android, iPhone, iPad, and Mobile Web! During the months leading up to the DIA 2012 Annual Meeting, everyone, whether registered or not, can access the most up-to-date event content including: Important announcements about new speakers, sessions, and networking opportunities Event preview materials List of exhibiting companies And more! Download. Android. Download. iPhone & iPad Download. Mobile Web Stay Informed...Opt In and update your email preferences. STAY CONNECTED » My DIA » About Membership » Get Involved » Follow DIA       DIA 2012 Annual Meeting Highlights: 22 Tracks featuring 270+ Educational Opportunities, including: Standards for Patients: Collaborations to Innovate Therapy Development A Challenge for the Industry: What Will it Take for a Sponsor to Use EHRs With a Regulated Research Protocol? Discussion with Former Center for Devices and Radiological Health (CDRH) Management Collaborative Partnerships in Drug Development: An Executive Roundtable Discussion Partnering for Impact in Global Health Implementation of the Physician Payments Sunshine Act: Now What? Meta-collaborations: A Call to Action DIA 2012 Executive Session: Pioneering Partnerships India Regulatory Town Hall List of Special Topics NEW TRACK! White Paper Showcase featuring: Philips Respironics: Value of Actigraphy in Clinical Trials Cape Code Clinical Research, Inc.: Enabling Remote Monitoring in Clinical Trials for Sponsors and Sites DAC Patient Recruitment Services: The Unique Relationship Between Global Patient Recruitment and Translation Management Quintiles: The New Health Report 2012: Rethinking the Risk Equation in Biopharmaceutical Development and Delivery Microsystems: Raising the Bar for Regulatory Submission Document Quality- A Collaborative, Transitional Approach Kelly Services Inc.: Free Agency is Here- Exploring Workforce Impact on Clinical Outsourcing Aptiv Solutions: Implementation of Adaptive Clinical Trials 20+ Tutorials Innovative Theater Presentations 500+ Exhibiting Companies 6 months FREE access to all audio-synchronized presentations   Program Overview   Register Online

25th Annual EuroMeeting - Submit an Abstract - Deadline 30 May 2012

Submit an Abstract - Deadline 30 May 2012         The Call for Abstracts for the 25th Annual EuroMeeting 2013 in Amsterdam is now open. With a focus on better public health protection, greater transparency of the processes and the rational use of medicinal products, the proposed areas for discussion for the EuroMeeting 2013 are classified into general disciplines including pharmacovigilance and regulatory affairs for medicinal products and medical devices, R&D and clinical trials. Download Call for Abstracts [PDF] | Submit an Abstract online The scope of presentations will cover the experience gathered after the implementation of the new pharmacovigilance legislative framework, as well as from the patients' and Health Technology Assessment (HTA) perspective. Experts and authorities in the fields will be presenting their considerations for debate. The Programme Committee is working on developing an engaging and thought provoking agenda that will address, among others, the new Pharmacovigilance Directive, the Falsified Medicines Directive, and Information to Patients. This is your chance to be part of next year’s programme. Programme Co-Chairs Beatriz Vicén Banzo, Head of Public Affairs and Technical Department, Bayer, Spain Peter Bachmann, Chair of The Co-ordination Group for Mutual Recognition and Decentralised Procedures (CMDh), Germany Submit an abstract for: Theme 1 - Health Technology Assessment (HTA)/Sustainability of Health Systems in Europe Theme 2  - Development of Medicinal Products for Paediatric, Elderly and other Special Populations Theme 3  - Legal Aspects/Transparency/Risk and Litigation Theme 4  - Pharmacovigilance Theme 5  - Clinical Research and Development Theme 6  - Quality (including Falsified Medicines) Theme 7  - Devices and In Vitro Diagnostics (IVDs) and Combination Products Theme 8  - eHealth Theme 9  - Involvement of Patients and Academia as Experts in the Drug Approval Process Theme 10- Known Active Substances Theme 11- Antibiotics Theme 12- Effectiveness and Efficiency of the EU Regulatory system - Does new legislation enable innovation and facilitate co-operation? Theme 13- Globalisation Theme 14- Regulatory Sciences Tutorials Download Call for Abstracts [PDF] | Submit an Abstract online With best regards, Your DIA EuroMeeting Team Important Dates 23-25 May 2012 6th European Conference on Rare Diseases and Orphan Products Brussels, Belgium 13th DIA Conference on European Electronic Document Management 28-30 November 2012 | Munich, Germany Call for Abstracts deadline on 30 April! Submit your Abstract today! The themes mentioned below suggest issues and topics the programme committee would like to have addressed and should serve as a valuable guide as you develop your abstract. You are invited to submit abstracts for presentations that fall under the following headings: LifeCycle management of regulated information eTMF Systems eArchiving eSubmission Guidelines  Submit an Abstract online

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UNC’s Emerging Company Showcase highlights new healthcare technologies, from MedCityNews

Innovation is brewing in Chapel Hill, North Carolina.
The University of North Carolina at Chapel Hill held its annual Emerging Company Showcase this week, an event that gives companies spun out of the university the chance to strut their stuff in an eight minute presentation before an audience of researchers, entrepreneurs and potential investors or partners.

This year’s showcase featured a total of 14 companies; eight companies in the scientific track, which encompassed technologies that have applications in healthcare or scientific work. Many of the companies have received support from Carolina KickStart, a UNC program funded by the North Carolina Translational and Clinical Sciences (TraCS) Institute. Carolina KickStart’s role is to provide support UNC faculty members who are looking to commercialize new biomedical technologies. Here are the scientific companies that presented at the event.

Augment Medical: Augment Medical aims to improve the ability of disabled patients to use the nurse call system. The Joint Commission, a hospital certification and accreditation body, has called for the hospitals to make the nurse call system accessible to all patients regardless of cognitive or physical ability by the third quarter of 2012. On Augment’s system, raising an eyebrow is all it takes to activate a facial sensor that triggers a call to the nurse. Future versions will have eye-tracking capabilities that bring the calling function to a tablet computer. The company was founded by graduate students in the joint departments of biomedical engineering at North Carolina State University and UNC. “We want to be the standard of care for The Joint Commission,” said Timothy Martin, Augment’s president and co-founder. The company last year was awarded a $7,000 grant from NC TraCS. The company is looking to raise $750,000 from investors or strategic partners.

GeneCentric Diagnostics: Taking a personalized medicine approach to cancer treatment, GeneCentric is developing new diagnostics to match a drug to individual patients in order to maximize the efficacy of cancer treatments and reduce adverse events. GeneCentric’s initial focus is nonsmall cell lung cancer, or NSCLC. The company’s diagnostic tests for the subtype of NSCLC, which is important because some currently approved drugs as well as drugs still in development work differently depending on the subtype. “We wouldn’t know which drug would work if we didn’t have the right diagnostic,” said Myla Lai-Goldman, CEO and co-founder. The company is based on research from Dr. Neil Hayes and Chuck Perou of UNC.GeneCentric raised $250,000 from Hatteras Venture Partners last year.

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