CALBIO2012 is a statewide conference produced by BayBio and BIOCOM that brings together the life sciences sector in California and beyond: company executives and innovators, government, medical research and disease foundations, university transfer offices, philanthropists and investors.

Built on the synergy between two leading life sciences clusters, CALBIO2012 identifies best practices and new models and fosters collaborations in research, development and product commercialization.


Especially these tracks & sessions:

http://www.baybio.org/baybio-sites/calbio2012/tracks/clinical-development/
Track 2
Clinical Development
Thursday, March 8, 2012

Session 1
Patient Advocacy: The Key to the Next Evolution of Clinical Development

The sleeping giant in clinical development is the patient, both as the crucial resource in clinical trials and as a previously under-utilized source of clinical/molecular data and biospecimens. Increasingly, product innovators are viewing patients as full partners. Novel collaborations with patient advocacy groups – who have access to large numbers of patients with a particular disease, who are motivated to drive and accelerate research, and who can bridge the silos of academe and industry – are emerging. Patient groups can also be supportive to the development of new models, such as adaptive clinical trials, that have the potential to produce better clinical outcomes in a shorter time frame. This session will explore the pro-active role of advocacy groups, how these types of collaborations are taking shape, how they might fuel a new generation of clinical development, what is needed to harness the potential of all the data, and how to avoid some of the common pitfalls.

Session 2
Ten Tips to Accelerate Clinical Trials and Do Them Well

In order to expedite the speed with which clinical trials are completed, it is critical to have a solid foundation for measuring and tracking where key improvements in process and efficiency can be made. There are general areas where sponsors can improve the speed of clinical trial completion, for example: decreasing time for subject enrollment and recruitment, decreasing site contracting time and speeding up site initiations. In this cost constrained environment, however, there is a cost benefit sponsors are willing to accept in order to save time and improve clinical trial performance. Due to the cost of making improvements, it is important to have key processes in place for identifying where changes can have the biggest bang for the buck. Processes for identifying key changes include: -Developing a balanced scorecard for selecting the right sites and investigators -Key criteria for streamlining the feasibility process -Establishing enrollment forecasting methodology -Optimal incorporation of feasibility and subject enrollment Once processes such as these are established, key areas can be identified for improvement. This approach has the benefit of decreasing sponsor expense by honing in on specific areas of improvement while accelerating trial performance and efficiency.

Session 4
Modernizing our Industry: Developing the Clinical Trials of the Future

The average drug costs over a billion dollars to develop, and takes more than ten years to get from the bench to the patient. Without question, the costliest, most time-consuming part of drug development is the process of clinical testing, however, most clinical trials are conducted in much the same way that they have been for the last 50 years. Could the cost of conducting clinical trials be reduced? Could we speed up the time in which it takes to get a drug through clinical testing? And, is it possible to design better clinical trials so as to avoid costly late-stage failures? New technologies and approaches now make the answers to all of these questions a resounding “yes”. This panel will focus on the future of clinical trials and what is being done to modernize the process of drug development. Panelists will discuss new recruiting techniques, mobile health technologies for remote patient monitoring, innovative trial designs and industry-wide consortiums that will ultimately revolutionize the way we conduct clinical trials, reducing costs and speeding drug development.
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http://www.baybio.org/baybio-sites/calbio2012/tracks/patients/
Patients
Track 3
Friday, March 9, 2012

Session 1
Taking Matters into Their Own Hands: The Role of Patients in Drug Development 

In major world markets, patients have emerged as a significant power in drug development, approval, reimbursement and communication. Patient organizations are playing a critical role in many cases, from co-creation of innovative therapies and delivery systems, to faster approval and wider reimbursement. For biopharma companies, a successful business model now relies on involving patients and advocacy groups in each stage of development: joint drug development and testing (injectable biologics such as Novo Nordisk’s insulin reached global success due in part to patient-friendly pens); collaboration in speeding approval from regulators, such as the role of patient groups in the fast approval of Novartis’s leukemia drug, Gleevec; understanding of patients’ experience of disease, such as Sanofi Genzyme’s close links with families of patients with Gaucher disease and other orphan diseases. This panel representing innovating biopharma companies, leading foundations/advocacy groups and key industry experts will explore the role that disease foundations and patient advocacy groups can and should play and discuss current best practices in successful company-patient collaborations throughout the value chain.

Session 2
Patient Access to Developmental Drugs

This session explores proposed regulatory innovation in the area of life-threatening diseases that have unmet medical need. Since the 1962 tightening of evidentiary standards for safety and efficacy, FDA has struggled to balance benefit and risk in a way that helps patients in need of treatment. Our one size fits all approach to drug approval has not allowed individuals to express their own preferences for risk versus potential health improvement, especially in deadly diseases for which no approved treatments are effective and the only chance at survival may lie with new investigational drugs. The panel session considers the effectiveness of FDAMA’s Accelerated Approval provisions and whether they have produced a net benefit to terminally-ill patients over the last 15 years. In the last 10 years, several initiatives for more meaningful progressive regulatory approval have been argued in Congress and in the Judiciary, including parallel-track and class-level authorization. We will examine these initiatives and discuss new draft legislation proposed by BIO and by Senator Kay Hagen (D-NC). The implications are not just human lives, but also dramatic reduction in regulatory risk for companies considering development in deadly unsolved diseases.

Session 3
Social Media and Life Sciences: Hearing a Patient’s Voice

700 million of anything is hard to ignore. The exponential growth of social media, with nearly 700 million Facebook users, is well documented with increasing numbers of life sciences companies looking at ways to interact with healthcare providers, patients and consumers through social media. The key question, however, is how do you connect the right people with the right message at the right time? During this panel discussion you will hear about latest social media developments and trends, limitations and major pitfalls. Learn about key innovators and what experiences might be relevant for your company.

I want to share an example of what PALS are doing to advocate for ALS research.  

This YouTube video promotes the National ALS Registry, supported by the Centers for Disease Control.  The ALS registry can play a vital role in learning more about ALS, such as risk factors for the disease or patterns over time.  The more PALS who enroll, the more valuable the information derived from it.  Registration is easy and gives access to surveys, which family members and caregivers are encouraged to get involved with.  By registering, you will be contributing to ALS research and potentially helping PALS in the future. 

Listen to Rick as he talks about why the registry is so important and about benefits for PALS.  Thank you Rick!

YouTube ALS Video

CDC Registry