Wednesday, May 15, 2013

Just Released: Formulation & Delivery Conference Agenda


We’re pleased to announce the release of IBC’s 13th Annual Formulation & Delivery Strategies for Biologics and Protein Therapeutics taking place this September.


Conference sessions provide predictive methods and innovative technologies for the rational development, production and delivery of next-generation biologics and protein therapeutics:
  • Particle Identification and Characterization for Realizing Stable, Safe and Effective Formulation
  • Analytical Strategies for Determining Formulation Stability
  • Biosimilar Formulation and QbD Considerations for Biologic Development
  • Localized and Targeted Delivery Strategies
  • And more!
This event will take place September 17-19, 2013 at the Hynes Convention Center in Boston, Massachusetts. It is co-located with the BioProcess International Conference & Exhibition. As a member of this group, when you register to join us and mention code B13166JP, you’ll save 20% of the standard rate. If you have any questions, feel free to email Jennifer Pereira.

Friday, April 26, 2013

Highlights from the 17th Annual Drug Delivery Partnerships Event


Couldn’t make it to last year’s event? We’ve got you covered! Check out our highlights below:

• Keynote Billy Tauzin, Former U.S. Congressman, Former President and CEO PhRMA spoke on the 2012 Election and where it left the Pharmaceutical Industry

• The 3rd Annual DDP Speed Networking Event provided the opportunity to meet and network with those executives who could potentially be your next blockbuster deal

• The 4th Annual Drug Delivery Innovation Awards recognized companies that have demonstrated exemplary, forward-thinking leadership in the field and/or which have developed delivery technologies with the potential to propel the industry in promising new directions.

To learn more, download the complete summary.

As part of our DDP Community, you will receive our new monthly newsletter that provides important event and industry updates. Thanks for being part of our community and stay tuned for more next month!

Cheers,
The Drug Delivery Partnerships Team

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Friday, April 19, 2013

Now Available: 2013 DDP Executive Summary

This past February, more than 300 professionals joined us at the 17th Annual Drug Delivery Partnerships event in San Diego, CA. Even with a blizzard brewing back home for many, there was a huge level of excitement and energy in the keynotes, sessions and exhibit hall over the course of three days. Many ideas, challenges and solutions were explored.

Want to learn more? Download our full executive summary.

As part of our DDP Community, you will receive our new monthly newsletter that provides important event and industry updates. Not a member? You can subscribe here. Stay tuned for more next month!

Cheers,
The Drug Delivery Partnerships International Team
 
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P.S. Save the Date! The 2014 Drug Delivery Partnerships event will be taking place on January 27-29, 2014 in beautiful Boca Raton, Florida.

Friday, March 15, 2013

Gold Nanoparticle Therapy approved for first clinical trial

Biomedical engineers may have found a way to treat tumors for the head and neck, as well as prostate cancer, in a minimally invasive way. The new treatment, referred to as Gold Nanoparticle Therapy, has already been approved by the FDA and the first trial will begin at the Cancer Treatment Centers of America.

The nanoparticles consist of microscopic balls of silica (glass) encased in a thin shell of gold. These nanoparticles are injected into the blood stream and absorbed by tumors—not healthy tissue. After 12 to 24 hours, when the particles have been absorbed by the tumor, an infrared laser is used to heat the particles and destroy the tumor cell. Tumors are damaged or destroyed with minimal effect on healthy tissues.

How will this change the way we control and treat cancer?


Friday, February 15, 2013

Congratulations to the Winners of the 4th Annual Drug Delivery Innovation Awards!



We would like to thank everyone for attending the 17th Annual Drug Delivery Partnerships event, we hope you gained as much from it as we did!

We are proud to announce this year's winners of the 4th Annual Drug Delivery Innovation Awards!

Industry Achievement: Unigene
Award info: Like the “Best Picture” winner at the Oscars, this category rewards the company that has shown the best all-around achievement in the drug delivery space.

 Technology/Company Innovation: Pearl Therapeutics
Award Info: Celebrate the ground-breaking technologies of your peers! This category rewards the company that has the most exciting delivery technology of the past year.

"On the Rise" Company: Nanosmart
Award Info: Celebrate the newcomers to the industry! This category rewards the company that is new to DDP and that has the most exciting potential.

Congratulations to this year's winner's, we look forward to seeing you all at next year's event!

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.

Thursday, February 7, 2013

#DDP13: Where does drug delivery fit in the Pharmaceutical pipeline?

This morning, event chair Sesha Neervannan, Vice President, Pharmaceutical Development of Allergan began by looking at the current buzz in the drug delivery industry: targeted delivery.  As an industry, we have great drugs, how do we get them to where they need to go? The move to biologics has brought the need to target the specific organ. Not only is targeted drug delivery a challenge but factors such as ethnicity, age and other items need to be considered. The goal is to get to individualized medicine. Devices are no longer an afterthought, now in drug delivery devices should be one of the first things considered.

This was followed by a keynote from David Pyott, Chairman, President and CEO of Allergan.  He presented "When Drug Delivery Creates a Blockbuster."  He started by giving background for on the company.  It was founded in Los Angeles in 1950. Pyott has only been the 3rd CEO in all the time that Allergan has been in existence. Most of research and development for the company is done in Irvine California while clinical development sites are in London and Tokyo among other places. The key business model is specialization and half of the company is ophthalmology, World wide in their specialites, they rank either #1 or #2.

As for the future of their timeline, in 2010 and 2011, they had seven FDA approvals. Peak sales of drugs take five/six years which means sales growth over the next few years is promising.  Allergan focuses on getting products approved and having a full pipeline. They've used drug delivery as a way to improve the patient experience.

Where Does Drug Delivery Fit into the Pharmaceutical Pipeline?  Speakers Roy Waldron, Senior Vice President and Associate General Counsel, PFIZER, Christopher Seaton, Senior Vice President, Global Licensing, BAYER PHARMACEUTICALS, James Hattersley, Vice President, Corporate Business Development, SUN PHARMACEUTICALS, and Simon Hartas, Vice President, Medicines Evaluation, Pharmaceutical Development, ASTRAZENECA were on a panel to discuss these topics.

Without adequate drug delivery and devices the compound invited is really useless.

What are the top priorities in selecting the drug delivery throughout the drug development process? Hartas of AstraZeneca believes it depends on where the compound is in the drug delivery phase. There’s a balance between speed and advanced delivery systems. The strategy of the process is a moving beast and done on a case by case basis. The advanced drug delivery system causes extreme ties and makes it very difficult to move back should something need to be done over.

Hattersley of  Sun Pharmaceuticals states that his company  focuses on differentiation and value proposition. They look at what’s on the landscape and what they have to offer. What will the innovation mean for the product portfolio they have? Changing products and product profiles need to be altered with what the patient wants and looking at the pricing and reimbursement side. Chris looks at whether or not there is value or differentiates the product. If it doesn't provide extra value, there isn't anything this specific delivery system can do for the company. There is no value to the company if there is no value created for the customers.

Sun Pharmaceuticals starts by designing their product and what they want it to look like as and end product and move backwards.  When taking the innovation to the FDA, they look at it from an aspect as to whether or not it’s new and novel followed by the safety.   Then the FDA will look at what does the system do? Hartas of AstraZeneca believes that novel drug delivery has the opportunity to open up new areas of science in terms of specific delivery and more in-depth delivery methods. Bayer Pharmaceuticals believes that a critical part of repurposing drugs is drug delivery is an important part of this. Sun Pharmaceuticals also counts on drug repurposing and states that a growing source of revenue and contributes to pipe line throughout the delivery system in a more beginning part of the process.