Showing posts with label Therapeutic Innovation and Regulatory Science. Show all posts
Showing posts with label Therapeutic Innovation and Regulatory Science. Show all posts

Monday, April 15, 2013

Editor in Chief's Commentary: Therapeutic Innovation & Regulatory Science | March 2013

Dr. Stephen SpielbergCommentary

Dr. Stephen P. Spielberg
Editor-in-Chief

I’m incredibly excited to have joined the DIA at a time when medical science is advancing at an ever-increasing rate. Building on the foundation laid down by the Drug Information Journal, Therapeutic Innovation & Regulatory Science, known as TIRS, is part of DIA’s efforts to ensure the flow of information to all our members – more than 17,000 around the world. The rate of accrual of new knowledge challenges all of us to assure that the brilliance of our science is converted efficiently and effectively into new safe, effective, high quality, and sustainably available medical products.

The title of our new journal implies innovation, and we intend to publish outstanding science reflecting innovation from molecular biology, drug development and clinical trials, through real world assessment. I hope we can create a practical and impactful forum for scientific exchange. Because we live in a time of rapid change in all disciplines characterized by increasingly dense language communication within our disciplines, so too we need innovation in communication, bringing together all who share in the drug development and utilization processes.

We hope to establish a broad-based editorial board reflecting disciplines traditionally thought of as part of the drug development and evaluation processes, and expanding and integrating new areas, including patient advocacy groups and health economists. Never before has accomplishing the goals of improved therapeutics been as much of a “team sport” as it is today, and TIRS will reflect these challenges and opportunities, in print and in collaboration with DIA in multiple other formats.

The “regulatory science” part of the TIRS name reflects the increasing need of all sectors, including the regulatory community, to work at the cutting edge of innovation, being neither advocates nor impediments to innovation, but dispassionate evaluators, in the words defining the US FDA both “protectors and promoters of the public health.” Using the neutral turf of the DIA, TIRS will be an integral part of bringing together all the players needed to advance human therapeutics.

A personal reflection as I join the DIA in this effort… I entered medical school more than 45 years ago, and have been privileged to witness the most remarkable advances in science and medicine in the history of humankind. I, and I am sure all DIA members, worry about the future, the sustainable implementation of science on behalf of us all. I worry when I hear discussions that separate “patients” from the rest of us. All of us, often in the flash of seconds of time, become patients, suddenly dependent on the therapeutics about which we have just opined. It is in all our interests to work together to “get it right.” Please join us at TIRS as we navigate this process, and help create a global forum for knowledge exchange and interpretation to raise the level of health and well-being worldwide.

Sign up today to have the latest news in drug development worldwide delivered to your inbox ~ DIA's Global Smartbrief.

Wednesday, February 27, 2013

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 (2nd 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

Monday, December 17, 2012

New DIA Member Benefits in 2013


Membership | Network, Learn & Lead
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& PublicationsMeetings & TrainingsSpeaking & PublishingNetworking & CommunitiesExhibiting
AdvertisingCareer Center
New DIA Member Benefits in 2013
 
2013 will be an exciting year for DIA Members. Here’s a quick summary of what’s new and different about your DIA member benefits in 2013:
Free for Members Only: Archived Webinars!
Your DIA membership now provides a NEW benefit: Enjoy one of our best-in-class archived webinars (online seminars) for FREE at your own work or home office location – a $295 value – as our “thank you” for being a member! DIA webinars provide timely and convenient access to leading industry and regulatory experts on a broad range of topics, giving you up-to-the-minute information about the latest developments in the medical product industries.
Therapeutic Innovation & Regulatory Science
It's launch time for our new peer-reviewed journal, Therapeutic Innovation & Regulatory Science (TIRS), look for your first issue arriving in mid-January! When our founders established the Drug Information Journal in the mid-1960s, our organization was primarily focused on the scientific and clinical development, and regulatory approval, of drugs. Today’s DIA members work on all product types (including but not limited to drugs), on topics such as comparative effectiveness, and on their supporting scientific and regulatory frameworks. We’ve adapted and changed the DIJ to TIRS to reflect this progress – and your interests.
Global Forum Going Digital in 2013
Your Global Forum member and industry news magazine will transition to a purely digital product in 2013. Don’t worry: We will continue to email you a direct link to each digital version and continue to post that link on our website. Add in your Global Forum iPhone and iPad apps, and your Global Forum will continue to Reach, Educate, Inform and Advise you no matter where you are.
DIA Online Member ConneX
New: Your Online DIA Member Directory will help you network globally AND locally, share documents and discussions, connect with colleagues and create your own network of thought leaders. Login at My DIA and choose Manage My Communities to access your personal network of global thought leaders and colleagues.

DIA SmartBrief International eNewsletter (Coming January 2013)
DIA SmartBrief is a must read for professionals interested in the latest news and information related to diagnostic and therapeutic product innovations and the science and regulatory considerations needed to ensure those products are safe, effective, and available to the public. Two times per week this enewsletter is delivered straight to your inbox and linked back to the original source so you can read further.
DIA Dispatch and DIA Global Regulatory Activity Digest
Since 2003, DIA has delivered regulatory updates through the DIA Dispatch and DIA Global Regulatory Activity Digest. Digital technology has greatly changed the news and communications landscape in the decade since past, and as a result these products will be discontinued in January 2013. We will invest these resources in new opportunities to enhance your member experience.

Don’t Forget!
  • DIA Members save on over 200 events, courses, books and online resources available through www.diahome.org. Members save an average of 20% on DIA’s regional Annual Meetings. Click here to take advantage of these exclusive members’ only discounts.
  • Renew for 2 years and save an extra 10%!  Email membership@diahome.org and reference this email to take advantage of this special offer.
  • Take advantage of all your member benefits!

We look forward to a great year in 2013!

DIA Member Services

Thursday, November 22, 2012

Membresía Electrónica ahora disponible para Latinoamérica! Todo esto por tan solo USD $35 al año


Noticias de
la DIA
News & PublicationsMeetings &
TrainingsSpeaking & PublishingNetworking & CommunitiesExhibiting AdvertisingCareer Center
Membresía Electrónica ahora disponible
para Latinoamérica!

Estimado Colega,
Porque usted lo pidió, ¡Nosotros cumplimos!
Nos complace invitarlo a ser parte de la comunidad de la DIA como Miembro. La Membresía Electrónica de la DIA, le proporcionará una serie herramientas digitales y recursos en línea, para mantenerlo a la vanguardia en lo referente a información clínica, recursos de conocimientos y noticias en materia regulatoria aplicadas a las ciencias y la industria del cuidado de la salud- Todo esto por tan solo USD $35 al año.
SAVE THE DATES
10th Latin American Conference on Clinical
Research (2013) | October 20-22, 2013 | Sao Paulo, Brazil
Adicionalmente, y como parte de los beneficios de su membresía, usted tendrá acceso a todas las herramientas y recursos citados a continuación. Para realizar su registro en línea, presione aquí o descargue la forma electrónica presionando aquí. Ingrese su país y escoja la membresía electrónica a partir de la lista.
  • Descuentos exclusivos para Membresías - electrónicas (eMembers) para asistir a las Conferencias Latinoamericanas de la DIA, así como mas de 200 oportunidades que ofrece la DIA a lo largo del mundo y vía web.
  • ¡Nuevo! Sólo para Miembros, consultas a nuestros seminarios en línea pasados. Aproveche los beneficios que ofrecen nuestros seminarios en línea, los temas de mayor relevancia, hasta la comodidad de su escritorio.
  • ¡Nuevo! Acceso a uestro Directorio de Miembros. Establezca contactos locales y globales, comparta documentos y participe en conversaciones estratégicas. Entre en contacto con otros miembros y cree su propia red de colegas y líderes de opinión de la industria.
  • Suscripción Digital (6 ejemplares incluidos) para:
    • ¡Nuevo para 2013! Suscripción a la publicación Therapeutic Innovation & Regulatory Science, Revisada por expertos de la DIA, revista académica (anteriormente Drug Information Journal)
    • Global Forum – Su revista de información digital, le ofrece consejos prácticos, actualizaciones en asuntos regulatorios y de la industria mundial.
  • Comunidades en línea y DIA ConneX: Sólo para miembros de la plataforma de enlace profesional y Áreas de Interés Especifico (SIACs) Grupos de interés específico de la DIA por disciplina, para compartir las mejores prácticas y la información de último momento relacionada con su campo de trabajo.
  • Centro de Avance Profesional de la DIA en línea- Fuente para encontrar y presentar oportunidades de empleo.
Si usted tiene alguna pregunta en relación a las suscripciones o membresía, contáctenos al correo membership@diahome.org.
Atentamente,
Alejandro Bermúdez-Del-Villar, MA/IBBD
Coordinador de Desarrollo para
Latinoamérica y del Programa Global
Alejandro.Bermudez@diahome.org

Latin America: get the latest clinical information, knowledge resources and regulatory news in the life sciences and health care industry with DIA electronic membership


News from DIA
News &
PublicationsMeetings & TrainingsSpeaking & PublishingNetworking & CommunitiesExhibiting
AdvertisingCareer Center
Electronic Membership now available
in Latin America!

Dear Colleague,
You asked, we delivered!
It is my pleasure to invite you to join DIA as a Member.  DIA’s electronic Membership provides with online tools and digital access to an outstanding collection of tools and resources to keep you ahead of the curve on the latest clinical information, knowledge resources and regulatory news in the life sciences and health care industry – all for just $35 a year.
SAVE THE DATES
10th Latin American
Conference on Clinical Research (2013) | October 20-22, 2013 | Sao Paulo, Brazil
In addition, as part of your membership you have access to all the below tools and resources. To register online, click here or to download a form, click here. Enter your country and choose eMembership from the dropdown list.
  • eMembers-only registration discounts on DIA Latin America conferences and over 200  DIA offerings across the globe and online
  • New! Members-only free archived webinars. Take advantage of a hot topic webinar as a complimentary member benefit – without leaving your desk
  • New! DIA Online Member Directory. Network locally and globally, share documents and discussions, connect with colleagues and create your own network of colleagues and industry thought leaders.
  • Digital Subscription (6 issues each) to:
    • New in 2013! Subscription to Therapeutic Innovation & Regulatory Science publication, DIA’s peer-reviewed, scholarly journal (formerly the Drug Information Journal)
    • Global Forum – your association digital news magazine featuring practical tips, regulatory and global industry updates
  • Online Communities and DIA ConneX: Members-only professional networking platform and Special Interest Area Communities (SIACs) – DIA’s discipline specific groups that share best practices and the latest information related to your field
  • DIA Online Career Center– your source to find and list employment opportunities
If you have any questions regarding membership or joining, please contact us at membership@diahome.org.
Sincerely,
Alejandro Bermudez-Del-Villar, MA/IBBD
Latin America & Global Program
Development Coordinator
Alejandro.Bermudez@diahome.org