Friday, February 8, 2013

#DDP13: The callenges of Innovations and Devices

We started off with a welcome from Lee Shorter, Director, Platform Technology and Science Disruptive Technology of GlaxoSmithKline.  He shared his three findings from yesterday’s sessions.  For the first time in quite a while, there is hope in this industry. He points out the path that Allergan has taken and towards Tauzen who is an amazing person who can speak for the Pharma industry in Washington. It's also important to realize the drug delivery industry is responsible for taking care of the patient, but also continue the innovation in the industry.

Our first keynote of the morning was Myshkin Ingawale, Inventor, Co-Founder, Biosense Technologies, TED Speaker.  He starts out by asking how we can driving innovation in healthcare for those who are making less than two dollars a day. His company Biosense was founded three years ago by engineers, designers and other innovative minds to focus on this. They realized that in India, iron deficiency is a serious problem and extreme cases result in mortality. There can be downfalls of innovation but it's critical to experience the pain early and often. This is why failing early, in small ways and often is critical to their success. He also focuses on the importance of build a team smarter than you. Everyone doesn't know everything, it’s important to get those who have their specialties to enhance the team.

Peter Staple, President and CEO, CORIUM presented A “Patient-first” Approach to Drug Delivery: Easy-to-Use, Safe Transdermal Systems for Biologics.  This company focuses on transdermal drug delivery.  Their two technologies are MicroCor for large molecules with a microstructure patch and a Corplex for small molecule delivery. When looking at the value of biologics, the industry is growing and on track to be the top Pharma sales item.  Most of the dosage forms are an injectable format. This form of delivery isn't optimal for many of the users of the medication.  Another compatibility issue is the refrigeration required for the dosage forms.  Drug delivery systems with complexity often avoid their therapies – one piece works best. Corium’s patch offers a delivery method that is stable and easy to use. There is no needle, no refrigeration, no sharps disposable, no long waits, no complex systems and it’s cost effective.

We concluded the morning keynote sessions with the panel "Drug Delivery Devices: How Are Devices and Combination Products Changing the Drug Delivery Game?."  Speakers included Philip Green, Senior Director, Biologics Device Strategy, Merck, Anke Liewald, SANOFI-AVENTIS
Patrick Jones, Global Director, Commercial Development, BD Medical-Pharmaceutical Systems,
Donna French, PhD, Senior Director, Device Development, Genentech and James J. Collins, Vice President, Drug Delivery and Device Research and Development, of Eli Lilly.

Jones of BD Medical Pharmaceutical Systems believes that so many aspects to device development, but as a device company, they focus on development and risks for their Pharma partners. Scale needed to design manufacturing and where the supply impact the device development. Support from both sides of the partnership is a critical key to success. The supplier needs to get this right in a partnerships with pharma and biotech. During the development process, it’s important to understand all characteristics that can impact drug efficacy, safety and compliance. Jones' company understands all things injection including the patient experience. So early in the partnership process, the device company needs risk mitigation early in the process. This is important so that during the due diligence phase,  the supplier can explain the data and provide functioning prototypes. In the development process, it’s about communicating reduced risk. The complexity has big impact on balancing risk and rewards and so the goal of the partnership is to reduce the risk upfront in the process. Each supplier is trying to do this.

Donna French of Genentech believes it’s important for the Pharma to work close with the suppliers during the process. The product and device are a system that work in concert together. There may be five suppliers that work together to make the combination product. They aren’t developing a primary container just for Pharma, but meeting the needs of all those involved. Pharma must ensure that they understand the design and manufacturing of the device.  The relationship is important because it’s a partnership to create the best device for the partners and the user.

On a similar note, Donna believes that it's critical to understand the interaction with the user and the the device.  So, a training process is needed for customer service who will be working with end users. The complaints process should be suitable for a combo product in terms of the user interface and communicated back to the product teams. The system needs to be able to track the user errors or mechanical issues.

Jones then moves into discussing the human factors and how they integrate into the use of devices.  As the human factors create a significant impact on the success of the device and is a large consideration in the investment of the product.  The supplier understands Pharma won't have an  in-depth knowledge of such things as usage of the product, so for success a device company should invest heavily upfront on user studies. They should be incorporated into the initial design.

No comments:

Post a Comment