DIA Spotlights Hot Topics in Drug Development and Regulation


Patient engagement, financial backing, and personalized medicine-3 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.

Patient engagement, financial backing, and personalized medicine—3 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% 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, Oregon, 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 6 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 am, 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 5 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, MD, 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, PhD, director of regulatory affairs for Novartis Pharmaceuticals Corporation, 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.



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