Aptiv Solutions speakers include Cynthia Nolte, Principal Regulatory Consultant, Helen Mayfield, Regulatory Consultant, and Brenda Faiola, Director Translational Sciences, who will be joined by Todd Brill, US Regulatory Affairs, EMD Serono, Inc., and Brian Lindsay, Quality and Regulatory Manager, Milliken Healthcare Products, LLC. Aptiv Solutions will also exhibit during the conference at booth #1540. For more details and to register visit the conference website.

Mr. Gutierrez brings over 25 years of industry operational and business development experience to Aptiv Solutions including significant senior tenure with Merck, Covance, and, most recently, MedAssurant, where he served as the Senior Vice President of Pharmaceutical and Life Sciences Operations.  Prior to that, he was with Covance for over 19 years where he advanced through the ranks, assuming commercial leadership positions of progressively greater responsibility. Mr. Gutierrez ultimately served as President, Periapproval and Market Access Services at Covance, where he also was an integral member of Covance’s Global Leadership Council.   Prior to joining Covance in 1991, Mr. Gutierrez worked in Business Development with Merck & Company.  Mr. Gutierrez received a bachelor of arts, with honors, from Harvard University and a master of business administration degree from Stanford University’s Graduate School of Business.

“I’m extremely pleased to have Luis join our growing company as part of the senior management team,” said Patrick K. Donnelly, Chairman and CEO at Aptiv Solutions, “He brings a depth and breadth of experience that adds to the already outstanding executive leadership team we have in place. With this appointment, Aptiv Solutions continues to add talented staff to help our clients in the design and execution of adaptive clinical trials and medical device development.”

 Mr. Gutierrez added, “I am thrilled to be joining Aptiv Solutions at a time when both regulators and sponsors are becoming increasingly enthusiastic about adaptive clinical trials and are changing requirements for medical device approvals. Aptiv Solutions is uniquely positioned to assist clients in addressing both of these changes and I look forward to further building our market presence as the leading provider of adaptive trial design, execution and clinical trial services.”

About Aptiv Solutions

Aptiv Solutions is a global biopharmaceutical and medical device development services company focused on recognizing, understanding and enabling clients to capitalize on rapid and fundamental changes facing companies developing products in the pharmaceutical, biotech and medical device market. The company offers clients an extensive portfolio of innovative services including adaptive clinical trials, translational research services, regulatory services, pharmacovigilance, clinical staffing and the operational support of a global clinical research organization. Aptiv Solutions has over 850 professionals in North America, Europe, the Middle East, Japan, and Australia. Visit the website at www.aptivsolutions.com.

While the FCC certainly does have jurisdiction over the frequencies used to transmit voice and data in the United States, it plays no part in the determination of which medical devices actually make it to market. In 2010 a recommendation was made by the FCC that it begin a joint program with the FDA concerning the regulation of mobile health products, but progress on that particular initiative has been slow and has so far had no regulatory impact.

The FDA has taken a proactive approach to wireless medical devices over the course of the past two years, releasing a draft guidance in 2011 that covered how mobile medical applications should be handled at the regulatory level. Medical Device Data Systems, regardless of whether the data is transmitted via public or private data carriers, are themselves defined as Class I medical devices in the Federal Register (76 FR 8637). ISO’s IEC 80001-1 is also available to health care facilities looking to adopt a standard for wireless network risk management.

Could the FCC conceivably play a role in the approval process for medical devices? It seems unlikely, given that the Commission has no existing resources to determine whether a given wireless device could negatively impact patient health or effectively treat a medical condition. The FDA has the remit and resources to assess whether a medical device is safe and efficacious. The FCC could, however, provide the FDA with experience and insight into how to better protect wirelessly-transmitted patient data, as well as how to avoid potentially harmful interference between different classes of wireless devices working together within the same institutional environment.

Benjamin Hunting
Aptiv Solutions Blogging Team

Let’s take a look at the top 3 technology trends for big pharma in 2012.

1. Leveraging Outside Tech Relationships. Large pharmaceutical companies are increasingly forming alliances with smaller biotech players in order to benefit from their technological prowess. Startups often lack the funding necessary to manage their own extensive clinical trials, which is where bigger organizations can prove useful. At the same time, the limited nature of these partnerships isolates pharma companies from much of the risk should the relationship not pan out. Startups provide the tech expertise, do all of the research, and lay the groundwork while larger companies benefit from these technologies down the road, adding agility to larger organizations more accustomed to slower decision-making.

3. Deploying adaptive clinical trials. Adaptive clinical trials design allows for pharma researchers to dynamically respond to data in order to pursue outcomes that offer the most value for a given investigation. The ability to better define the effective dose and other key trial factors can provide significant cost advantages over traditional randomized clinical trials while focusing on the data that is most relevant to a given study. Adaptive trials also provide greater efficiencies in resource management, which further adds to the bottom line.

3. Mining data pools. More and more drug companies are turning to electronic health records databases in order to seek out links between prescriptions, treatments, and outcomes. Analyzing this information costs far less than a clinical trial, yet can identify adverse reactions, the consequences of non-compliance, and drug interactions. This information can then inform future drug development, alter the course of current treatment strategies, and improve the ability of pharmaceutical organizations to meet patient needs. As data processing technology improves over time, the value of electronic health records to pharma companies will continue to rise.

Benjamin Hunting
Aptiv Solutions Blogging Team

In a survey on Adaptive Trials conducted in 2009, by Perceptive Informatics and Cytel, 500 pharma professionals were asked what they perceive as barriers to the implementation of adaptive clinical trials. Thirty-five percent of respondents were concerned about the acceptance of adaptive trials by regulatory agencies, thirty-three percent believed that there is a problem with the understanding of novel techniques, and twenty-eight percent listed the rapid access to clinical endpoint data as a concern. The respondents also listed other barriers, including problems with understanding and implementing complex statistical methodologies, and difficulties with estimation of medical supplies and supply chain management.

In relation to the acceptance by regulatory agencies, a major step forward was taken in February 2010 with the release by the FDA of  the “Draft Guidance for Industry on Adaptive Design Clinical Trials for Drugs and Biologics; Availability”. This 41-page document, which has been open to comments and discussion, lays down a number of important considerations for executing adaptive trials and provides a very useful framework for sponsor companies to follow. The evolving acceptance of adaptive trials was recently reflected in a February 2012 Wall Street Journal article by Dr. Scott Gottlieb, former FDA Deputy Commissioner for Medical and Scientific Affairs, who now considers adaptive trials a significant part of the new business model of big pharma.

The other barrier to adaptive trials is the lack of understanding of novel techniques or statistical methods by professionals engaged in clinical research. Industry and professional societies are tackling this issue by including the topic of adaptive study design and implementation on their conference and event programs, such as those at CVCTEC 2012, FDA/DIA Statistics Forum 2012, PSI 2012, and ADAPT 2012.

Concerns about the access to interim data and breeching the integrity of adaptive clinical trials by violating the blinded approach and introducing operational bias can be overcome by careful planning, the design of specific working procedures that cover adaptive operational processes, the use of implementation technology specifically developed for execution of adaptive trials that supports these processes, and the effective use of firewalls and encryption techniques that control both the access to real time data and how the data is used.

Finally, the management of timely medical supply for study participants is a logistical problem for adaptive trials. While such clinical trial supply management systems exist, (http://www.pharmaceutical-int.com/article/implementing-and-managing-adaptive-designs-for-clinical-trials.html), these systems  need to be fully integrated with both the EDC system and the randomization system to enable fast interim analyses to be undertaken. To date only one such system exists: AptivAdvantage.^TM 

Lisa King
Aptiv Solutions

The prospects are daunting, even for industry veterans. As costs for drug development continue to rise, revenues are projected to remain flat or nearly so for the foreseeable future. This economic pressure combines with a relatively empty product pipeline due to diminishing returns from research and development and the rising number of late-stage Phase III trial terminations. Underscoring the situation is a growing need for drug companies to not only justify the cost/benefit ratio of their current and future product lineup, but also bow to increasing pressures from governments, insurance companies, and payees to squeeze as much value out of a given treatment as possible.

As patents on major cash-earning drugs expire and the viability of the ‘blockbuster’ development strategy looks to be fading, Phil Birch provided an interesting perspective on what adaptive clinical trials have to offer companies that can no longer afford to invest huge sums into overpowered randomized clinical trials of uncertain value. Read more about the changing landscape of research and development in the drug industry by accessing the full interview here.

Benjamin Hunting
Aptiv Solutions Blogging Team

The crux of the argument made by Innovations in International Health at MIT program director Jose Gomez-Marquez is that the economic realities faced by doctors and nurses in developing nations have created a subculture where alternatives to expensive devices are commonplace. Gomez-Marquez makes the case that many of these innovative solutions to problems exacerbated by small budgets and poor access to resources rarely gain international attention due to the difficulties associated with publishing in recognized medical journals. He also mentions that the prototype-style design of these types of medical devices also pushes some practitioners away from displaying their work as it does not match up with the slick, industrial look of mass-produced medical equipment.

The Little Devices group hopes to provide a platform for medical device prototypes languishing in the practices of thousands of health care professionals spread out across the world. By examining the ‘do-it-yourself’ approach to design, the goal is to introduce substantial cost efficiencies into the American – and global – health system by taking advantage of proven, results-driven device engineering. Sharing these lessons with the medical community at large and transmitting the message to practitioners and patients that their input into the design and functionality of the medical devices they come into contact with every day is valuable and vital, and could potentially foster a movement to simplify and streamline the current thinking behind a wide range of products.

Benjamin Hunting
Aptiv Solutions Blogging Team