Navigation Links
DIA Spotlights Hot Topics in Drug Development and Regulation

Horsham, Pa. (PRWEB) June 05, 2013

Patient engagement, financial backing and personalized medicine—three of the most pressing issues in drug development and regulatory affairs—will be discussed at length at the DIA 2013 49th Annual Meeting, June 23-27 in Boston. Today’s thought leaders, decision-makers and patient advocates will have a unique opportunity to collaborate and share knowledge with today’s top minds in medicine.

Sessions during the meeting to be held at the Boston Convention & Exhibition Center will draw attention to advancements and challenges associated with all aspects of the drug development process. The sessions will dive more deeply into these topics, featuring expert insight from leaders in drug development and regulatory affairs, and highlighting moving stories behind these issues that illustrate their impact.

  •     Patient engagement: The patient voice continues to play a growing role as patient involvement becomes more valued by researchers, the pharmaceutical and medical device industries and government regulators.
  •     Financial backing: While regulatory reform is important in accelerating innovation in the industry, increased investment is even more vital. It is only by finding investment solutions that the growth of the industry, and exciting advancements, will be possible.
  •     Personalized medicine: The market for personalized medicine is projected to grow about 10 percent annually. Advancements in genomics have created ample opportunities for personalized medicine to emerge in the health care industry. One challenge is the high cost relative to the small size of patient populations.
Patient engagement as a driver for innovation
Cindy Hahn’s daughter, Alaina, was diagnosed with Alagille syndrome as an infant. With no previous medical experience, Hahn played a new role as patient advocate. Her inspirational drive to find a cure not only has advanced clinical research and drug development that may save her daughter, but also illustrates the vital role patient advocates can play in advancing the development of and access to new therapies. Hahn, from Tualatin, Ore., now chairs the DIA Patient Advocate Fellowship Alumni Program and continues to advocate on behalf of her 22-year-old daughter and patients with rare and liver diseases worldwide. Hahn will chair the session called Rescuing and Repurposing Drugs: Challenges and Opportunities to discuss the advantages and challenges of repurposing drugs to spur the drug development process, particularly for rare diseases.

Hahn will be joined by six other patients and advocates—including Utah Assistant Attorney General and rare disease patient Steve Mikita—who will share their moving stories of navigating the drug development pipeline to find therapies and discuss how to better include the patient voice in all phases of development. Their unique patient advocacy panel, held on June 24 at 10:15 a.m., is open to members of the media as well as meeting attendees.

With the key to drug development resting on patient involvement and recruitment for clinical trials, caregivers need to be encouraged to allow patients to participate. Leading researchers on how to engage parents in clinical trials will present in the session called Parents as Partners: Engaging Caregivers for Pediatric Trials.

Another session, Advancing Alzheimer’s Innovation: Patient Advocacy, Caregiver Support and Health Care System Impact, will focus on how the patient voice and caregiver support can advance innovation in Alzheimer’s research. Presenter Cynthia Bens, vice president of public policy for the Alliance for Aging Research, will discuss best practices in supporting patients and caregivers to advance collaboration between patients, industry and regulatory affairs.

Managing the cost of doing business
Compared with 10 years ago, finding the capital to finance drug development is more difficult, especially for small and medium-sized organizations. The cost of developing a drug has rocketed over the past decade, from an average of $800 million in 2002 to $4 billion in 2012. Industry professionals say that over the next five years, the return on investment will be insufficient for attracting the funding critical to advancing research, development and commercialization.

How does one navigate identifying and funneling money through the financial pipeline?

Unique collaborations may hold the key to accessing funding. Badri Rengarajan, M.D., medical director of Archimedes Inc., will lead an in-depth discussion in Unique Nonprofit-Industry Partnerships to Develop and Disseminate Technology, addressing barriers to technology development, such as a lack of funding, and how nonprofit partnerships can help overcome these hurdles. Citing real examples, such as the Merck-Regenstrief Institute partnership, the panel will discuss how funding from foundations can finance the development process.

Companies across the drug and medical device industries are transforming research and development (R&D) models as the economic climate evolves. The session called Reinventing the R&D Business Model: Heeding the President’s PCAST Report on Innovation, hosted by the Tufts Center for the Study of Drug Development, will examine how R&D business models are adapted to meet current and future market demands. Kenneth I. Kaitin, Ph.D., director of the Center for the Study of Drug Development at Tufts University School of Medicine, will lead the session.

The session called Payer Collaborations with Pharma: Real-world Evidence to Improve Patient Outcomes and Influence the Pipeline will focus on the objectives and outcomes of payer/pharmaceutical real-world evidence collaborations, presented by high-profile pharmaceutical representatives and payers who will share their goals, vision and experiences of their collaborations.

Making it personal
The market for personalized medicine, with a value of $232 billion in the United States, is projected to grow exponentially, especially among medium and large companies and R&D firms. Across the board, industry professionals rank high development costs as the most challenging aspect of growth and opportunity in personalized medicine.

Orphan product developers face unique challenges that multiply when combined with the need for co-registered diagnostic devices. The Roundtable on Personalized Therapy Innovation in Rare Disease: Focus on Public Policy, led by Jeffrey Stuart, Ph.D., director of regulatory affairs for Novartis Pharmaceuticals Corp., will define innovative strategies to speed development and access to orphan drugs and medical devices.

“Big data,” including comprehensive medical, patient, payer and real-world health outcome insights, present new opportunities to advance personalized medicine. In the session called Big Data: Impact on Innovation, moderated by Susan Dentzer, senior policy adviser at the Robert Wood Johnson Foundation and former editor-in-chief of the leading policy journal Health Affairs, will discuss how big data may soon transform patient care. The session called Changing Landscape of IT in the Pharmaceutical Industry features a presentation by Wanmei Ou, product strategist for Oracle Health Sciences, on managing big data to accelerate personalized medicine.

The future of personalized medicine depends on the development of rational reimbursement and coverage policies. The session on Developing Effective Policy Strategies for Coverage and Reimbursement of Companion Diagnostics will discuss the reimbursement landscape and trends with respect to coverage and reimbursement of diagnostics and give guidance to discussions with payers for appropriate coverage decisions.


ABOUT DIA: DIA is a neutral, global, professional and member-driven association of nearly 18,000 professionals involved in the discovery, development and life cycle management of pharmaceuticals, biotechnology, medical devices and related health care products. Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies and services to improve health and well-being worldwide. Headquarters are in Horsham, Pa., USA, with offices in Basel, Switzerland; Tokyo, Japan; Mumbai, India; Beijing, China; Washington, D.C.; and Latin America. Visit our website at and follow DIA at: LinkedInLinkedIn, Twitter, YouTube, Facebook, Flickr and Pinterest.

Karin Meadows, 202.559.4447, kmeadows(at)reingold(dot)com
Tiffany Cohen, 202.499.4411, tcohen(at)reingold(dot)com

Read the full story at

Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related medicine news :

1. Epicor Customer Conference 2013 in Nashville Spotlights the Latest Technologies to Drive Performance and Productivity, Including doc-link by Altec
2. Rap Star’s Hospitalization Spotlights the Dangerous Popularity of “Purple Drank,” advises Passages Malibu
3. Medical System Marketing Spotlights Women’s Heart Health
4. WeightWise Infographic Spotlights Twinkies Ingredients’ Non-Food Uses
5. PhD Box invites contributions for Research Topics Contest
6. HREI™ Selects the Top 10 Healthcare Real Estate Topics and Trends of the Past 10 Years
7. Suicide prevention, telemedicine among topics at Mayo Clinic Transform 2012
8. New heart attack definition to be launched at ESC Congress 2012 topics: Myocardial disease
9. Information Innovators Inc. (Triple-i) Acquires Leading Software Development Company, GoldBot Consulting Inc.
10. Vaginal Mesh Lawyers at Bernstein Liebhard LLP Note Recent Developments in Federal Transvaginal Mesh Lawsuits
11. Voices Against Brain Cancer Comments on New Potential Development in Brain Cancer Treatment
Post Your Comments:
(Date:10/13/2017)... ... October 13, 2017 , ... ... Randall, PharmD ‘17, and Jennifer Huggins, PharmD ’17, along with clinical associate ... primary prevention of cardiovascular diseases during the 15th Annual Women’s Health Conference. ...
(Date:10/13/2017)... ... 2017 , ... Many families have long-term insurance that covers care for a ... waiver for care if the client has a cognitive impairment diagnosis. , “What ... is often waived, so the benefits from their insurance start immediately,” said Mechell Vieira, ...
(Date:10/13/2017)... ... ... Global Healthcare Management’s 4th Annual Kids Fun Run brought out many kids ... sponsored by Global Healthcare Management’s CEO, Jon Letko, is aimed at getting kids excited ... all ages; it is a non-competitive, non-timed event, which is all about having fun ...
(Date:10/13/2017)... ... October 13, 2017 , ... Coveros, a leader ... been awarded a contract by the Center for Medicare and Medicaid Services (CMS). ... the enterprise use of Agile methodologies in a consistent and high value manner ...
(Date:10/12/2017)... Del. (PRWEB) , ... October 12, 2017 , ... ... and advisory services for healthcare compliance program management, will showcase a range of ... National Association for Assisted Living (NCAL) Convention and Expo to be held October ...
Breaking Medicine News(10 mins):
(Date:10/12/2017)... Pa. , Oct. 12, 2017 ... leader in innovative solutions for injectable drug administration, today ... before the market opens on Thursday, October 26, 2017, ... the results and business expectations at 9:00 a.m. Eastern ... (U.S.) or 253-336-8738 (International). The conference ID is 94093362. ...
(Date:10/10/2017)... Oct. 10, 2017  NDS received FDA 510(k) clearance in May ... battery-powered display stand specifically designed for endoscopy environments. An innovative secondary ... a clinical solution to support the improvement of patient outcomes, procedural ... ... ...
(Date:10/4/2017)... , Oct. 4, 2017  According to the Centers for Disease Control ... of October . PhysicianOne Urgent Care is helping communities across ... NY , by offering no-cost* flu shots through the end of ... by certain health insurance regulations. ... best time to get a flu shot is by the end of ...
Breaking Medicine Technology: