On May 21st, 2012, I attended an event organized by the non-profit organization Women In Bio (WIB), and what a blast! It was a very original set-up (at least for me): A speed networking.

WIB is a non-profit organization of professionals committed to promoting careers, leadership, and entrepreneurship of women in the life sciences. Women In Bio actively supports entrepreneurship and career growth for women involved in the biosciences.

Have you ever felt awkward at a networking events because you don’t want to bark in the middle of a discussion or just randomly start talking to somebody? Well speed networking definitely enables to avoid that :)

The principle is of course very similar to speed dating: You have a couple of minutes to get to know a person and see how well you hit if off. The organizers had put four long tables, and every four minute when the gong would ring, we all had to move one chair on our right.

This is an efficient way to meet new people and network, I have to say. I don’t think I have talked to so many people, learned about what they do, what their business was about, and talked about my company, in such a little time frame. In addition, all the women that attend the WIB events are so passionate! Talking to these driven, great individuals is definitely inspiring.

This was one of the most fun industry events I attended. Kudos to the WIB group and the organizers of this event.

Visit their website for more events: http://www.womeninbio.org/

Author: Sophie McCallum, Marketing & HR Manager at Clinovo, sophie.mccallum@clinovo.com

This paper argues that the development process for experimental drugs could be accelerated without significantly endangering the Public’s health thus saving lives and cutting cost.

Drugs access takes too long

Industry lobbyists continue to push for a more streamlined process to quicken the FDA approval time for certain high-risk devices, and often seek approval in the EU first.  Animal (pre-clinical) studies take three to four years to collect enough information to submit an Investigational New Drug Application (IND), followed by five to six years of clinical studies, and about one year for the FDA review of the NDA. The entire process takes, on average, seven to ten years before a new drug can be introduced to the market.

Time is money for some, life-and-death for others

Investigating and testing the safety and efficacy of new drugs is a costly endeavor for the pharmaceutical industry.  According to Forbes, the average cost of bringing a new drug to market has reached $1.3 billion in 2011. Once a drug is approved by the FDA, pharmaceutical companies have just a few years to ‘monetize’ their R&D investment, until the expiration of the patent. The imminent arrival of the dreaded “patent cliff” has been haunting the pharmaceutical industry for. With patents on many blockbuster drugs about to expire, an estimated $250 billion in sales are at risk between now and 2015, according to data from EvaluatePharma.

Hence a major factor in the return on investment (ROI) of drugs is the relatively short window of time a company has the monopoly of the market. According to a new study from consulting firm Oliver Wyman published in Life Science Leader magazine, the value generated by $1 invested in pharma R&D has fallen by more than 70%.

Needless to say, in addition to saving lives, an accelerated development process would have a beneficial effect on the cost of the drug.

Safety concerns

The concept of accelerating new drug access is appealing, but the question is: What phase of the development process should be accelerated and how, all while preserving public safety? Development process improvements leading to faster drug access must however be balanced with potential risks they may pose to public safety.

Phase III & NDA review process improvements

Phase III are complex, multicenter studies potentially involving several thousand subjects.  Their goal is to authoritatively assess a drug’s effectiveness and side effects against the currently available therapies, if such exist.  To scientifically prove result repeatability, the FDA often requires two successful Phase III trials.  Because of their large size, geographical distribution and the complexity of studies undertaken, they have a good potential for process improvement and acceleration.

Computer systems have been used in the past decade to capture and analyze study information.  However, these systems are hard to use and not integrated with other clinical systems such as Safety Systems and Clinical Trial Management Systems (CTMS).

Pharmaceutical companies should aim to raise productivity by:

• Using integrated systems to capture and analyze information submitted to the FDA.
• Speeding up subjects recruitments. The length of clinical trial for drugs treating life-threatening diseases could be reduced to one year by improving subject enrollment.
• Running multiple phases III in parallels
• Embedding FDA investigators in studies

Read full paper here

Author: Marc Desgrousilliers, CTO at Clinovo,  marc.desgrousilliers@clinovo.com

• OpenClinica has committed to a quicker turn-around on fixing bugs
• OpenClinica is gaining very strong momentum in Academia to the point that many universities IT department are forced to drop their home-grown EDC applications to standardize on OpenClinica
• I have met a number of individuals and companies that have run over 20 studies with open source EDC
• OpenClinica can work and go through formal software validation on the Cloud
• Companies are starting to build Android interface that uses OpenClinica in the back-end

I have also noticed that the attendees from the OpenClinica conference are even more friendly than most other conferences. I guess open technologies are adopted by open people  Hats off to Ben Baumann and his team on a very successful 2012 conference! If they are able to speed-up the development of new features while minimizing software bugs, I have no doubt they will be the dominant EDC player within a few years.

Ale Gicqueau,

President & CEO at Clinovo

ale.gicqueau@clinovo.com

There is a general consensus that the old paper-based data management tools and processes were inefficient and should be optimized. Electronic Data Capture has transformed the process of clinical trials data collection from a paper-based Case Report Form (CRF) process (paper-based) to an electronic-based CRF process (edc process).

In an attempt to optimize the process of collecting and cleaning clinical data, the Clinical Data Interchange Standards Consortium (CDISC), has developed standards that span the research spectrum from preclinical through postmarketing studies, including regulatory submission. These standards primarily focus on definitions of electronic data, the mechanisms for transmitting them, and, to a limited degree, related documents, such as the protocol.

Clinical Data Acquisition Standards Harmonization (CDASH)

The newest CDISC standard, and the one that will have the most visible impact on investigative sites and data managers, is Clinical Data Acquisition Standards Harmonization (CDASH).

As its name suggests, CDASH defines the data in paper and electronic CRFs.

Although it is compatible with CDISC’s standard for regulatory submission (SDTM), CDASH is optimized for data captured from subject visits, so some mapping between the standards is required. In addition to standardizing questions, CDASH also references CDISC’s Controlled Terminology standard, a compilation of code lists that allows answers to be standardized as well.

Example: Demographics (DM)

*CDASH recommends collecting the complete date of birth, but recognizes that in some cases only BIRTHYR and BIRTHMO are feasible.

* *This document lists four options for the collection of Sex: Male, Female, Unknown and Undifferentiated (M|F|U|UN). CDASH allows for a subset of these codelists to be used, and it is typical to only add the options for Male or Female.

The common variables: STUDYID, SITEID or SITENO, SUBJID, USUBJID, and INVID that are all SDTM variables with the exception of SITEID which can be used to collect a Site ID for a particular study, then mapped to SITEID for SDTM.

Common timing variables are VISIT, VISITNUM, VISDAT and VISTIM where VISDAT and VISTIM are mapped to the SDTM –DTM variable.

Note: Certain variables are populated using the Controlled Terminology approach. The COUNTRY codes are populated using ISO3166 standards codesfrom country code list. This is typically not collected but populated using controlled terminology.

Each variable is defined as:

• Highly Recommended: A data collection field that should be on the CRF (e.g., a regulatory requirement).
• Recommended/Conditional: A data collection field that should be collected on the CRF for specific cases or to address TA requirements (may be recorded elsewhere in the CRF or from other data collection sources).
• Optional: A data collection field that is available for use if needed

The CDASH and CDICS specifications are available on the CDICS website free of charge. There are several tool available to help you during the mapping process from CDASH to SDTM. For example, you could use Base SAS, SDTM-ETL or CDISC Express to easily map clinical data to SDTM.

In general you need to know CDISC standards and have a good knowledge of data collection, processing and analysis.

With the shift in focus of data entry, getting everyone comfortable with using a particular EDC system is a critical task for study sponsors looking to help improve the inefficiencies of the clinical trial data collection process. Certainly the tools are available that can be used to help clinical trial personnel adapt to new processes and enjoy better productivity.
Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, OpenClinica Open Source and Oracle Clinical.

Read original post blog here: A New Way to Collect Data – CDASH

“Initiating the study design and protocol process in a structured manner while incorporating CDISC standards use drives efficiency throughout the entire study life,” said David Gemzik, Chair of the Protocol Representation Group. “The Toolkit creates a foundation upon which a standards-driven approach can be implemented.”

The next release of the Toolkit, coming later in 2012, will include the PRM Protocol Wizard. The Wizard will allow the end user to simply “plug and play” different protocol elements into a simple-to-use web-based form. What once took hours to reengineer into different formats will require only a few ‘button clicks.’ The underlying technology for the PRM Protocol Wizard is being contributed by Medidata Solutions, a longtime CDISC Member Organization and Registered Solutions Provider. “Support for industry standards is a crucial part of Medidata’s vision for optimizing clinical research,” said Michelle Marlborough, Director of Product Management at Medidata.

“We are very excited that with the PRM Protocol Wizard, the final frontier for clinical research standards has been breached.” “We are extremely pleased that Medidata has offered this Toolkit openly to CDISC members to streamline their research, from protocol development throughout the study process to reporting,” said Rebecca Kush, President and CEO of CDISC. “This is what has been missing from the PRM since Version 1.0 was released in 2010; it provides a means for protocol authors to use the model without having to be technology experts.”

Discover an interview of Ale Gicqueau, President & CEO at Clinovo, and learn more about our services and our vision in the CRO industry. This video was broadcasted by Sy Truong at the last Wuss Conference in San Francisco.

• John Brega (PharmaStat) CDISC Implementation and eCTD Submissions
• Carey Smoak (Roche Molecular) Senior Manager, SAS Programming and CDISC Device Team Leader
• Dave Borbas (Jazz Pharmaceuticals) Senior Director, Data Management
• Ale Gicqueau (Clinovo) President & CEO

An appealing concept

The BioCenter was founded in 2004 in collaboration with the city of San Jose and the San Jose University Research Center. The facility is 40,000 sq ft and houses about 20 companies and will soon be expanding to almost double its current size. While touring the facility, I saw people from multiple companies going in and out of labs and office spaces, all with the common goal of elevating life through better pharmaceutical, better diagnostics, or bettering the environment.

I met with 2 people from one of the companies in the incubator who are developing a bacterial detection platform for molecular diagnostics. The company in entirety is 7 people, a common theme of the BioCenter. It is an electric environment to see these small companies sharing this large facility. The BioCenter has been at 100% occupancy for the last 5 years. During the crisis in 2008-09, they found a shift from less life science to more cleantech companies moving in, an interesting trend that has stuck with me.

A convenient format to nurture promising research

Some interesting things I learned about the BioCenter and its occupants are that the success rate coming from the incubator is not only high, but often very profitable. Companies have emerged from the space, garnering deals worth 50, 80, even 130 million dollars. A benefit to the companies who do not make it out of the facility is that with this plug-and-play format, decisions can be made quicker and at lower costs, allowing funds to be redistributed to more successful ideas.

I believe that such places play a great role in fostering research, it allows researchers, indivually or in small cells, to start a research program without a big investment and it lowers the risk. At the end of the day, more innovations can be brought to the market.

The event was a great opportunity to learn about the BioCenter as well as meet the tenants. The atmosphere was relaxed, they had yummy bites and my favorite beer, and overall was an evening well spent.

Check out the BioCenter at http://www.sjbiocenter.com to see for yourself what I experienced first hand.

Joshua Elvert
joshua.elvert@clinovo.com
(408) 940 3934