Drug Delivery Hits It Big In Vegas

By Lori Clapper, Editor

Pharma and biotech experts from around the globe gathered in Las Vegas from January 25 to 27 for Drug Delivery Partnerships 2012 (DDP). Vegas seemed an appropriate location, because drug development is a high stakes game filled with risk and reward. Veterans can attest that it takes years of careful research and "high roller" capital to develop just one drug from hundreds of potential candidates all the way through to commercialization. So many folks are willing to roll the dice on ideas and translate them into medicines to make us feel better. I, for one, am grateful for the people who make it their passion to discover and implement new ways to enhance our well-being through drug development — especially this time of year, during peak cold and flu season. The DDP conference was filled with a variety of content, excellent discussions, and plenty of time to network with such professionals.

Big Molecules Present Big Challenges
Biologics was one of the buzzwords for the week at DDP. Given the unstable nature of these therapeutics, their development can be quite a crap shoot. In his presentation, Jan Jezek, CSO, ARECOR, talked about the number of interactions that affect biologics, including chemical, charge-charge, and hydrophobic. To address these issues, Jezek said, researchers are modifying protein characteristics by selecting formulation conditions and removing excipients that cause unfavorable interactions.

Once biologics are developed, they obviously need to be delivered safely to the patients. Janssen's Weiguo Dai, Ph.D., fellow of drug delivery and device development, said the "safely" part is a roadblock in the cold chain and explained how patients could benefit from biologics that do not require cold chain shipping. According to Dai, patients worry about paying for medications that might not work as a result of temperature excursions, and they feel inconvenienced by having to be home for delivery to prevent such excursions. Dai also believes patients often fret over the prospect of having to allow certain injectable medications to warm up for 30 to 60 minutes before use, concerned that they may get sidetracked doing other things and let the product sit out too long.

Big Challenges Require Big Plans
Keynote speaker Lee Shorter, Ph.D, Platform Technology and Science Open Innovation, GSK, gave his insight on where he thinks the pharmaceutical industry is going. He outlined seven general areas of future growth in the industry:

• More R&D conducted in partnership with external experts, such as university researchers
• Fewer blockbusters with smaller drug launches
• Study of the human genome may start to pay off
• Biologics/biopharmaceuticals market will grow
• Vaccines become increasingly important for disease prevention, rather than for treatment of disease, especially in the developing world
• Innovative drug delivery techniques need to add value
• Pharma companies partner more on product development, for example Pfizer and GSK partnering on an HIV drug

Mark McClellan, director of the Engelberg Center for Health Care Reform, gave a high-speed, information-packed keynote address. One of the interesting takeaways was the need to expedite FDA drug approvals. McClellan emphasized that the FDA should communicate more with drug companies during the drug review cycle, and those interactions need to happen sooner. He also proposed the review cycle should be shorter, especially for treatments that may represent substantial improvements over those already in existence.

Big Plans Provide Big Hope
Through video and captivating images, Marc Koska, philanthropist and inventor of the K1 Auto-Disable (AD) syringe, gave a riveting presentation on the efforts by his charity, Safepoint, to address the problems that result from the re-use of syringes. According to Koska, syringes are re-used an average of four times in the developing world, which heightens the risk of infecting innocent people with blood-borne diseases like HIV and Hepatitis B and C. The K1 AD syringe is an inexpensive and easy-to-use solution for doctors to prevent the spread of these blood-borne diseases.

John Baldoni, Ph.D., senior VP of pharmaceutical R&D, GSK, brought the importance of drug development home during his presentation. What struck me the most was how he emphasized the human factor as the reason he, and others like him, get up and go to work every day. Baldoni explained that once a month, GSK invites an employee who is also a patient to come into the to the corporate headquarters to share their experiences of diseases, treatments, and the effect it has on them and their families. In so doing, GSK R&D employees realize the importance of their work — not just to a number in a clinical trial, but to a colleague, a person with fears, feelings, and families. According to Baldoni, "90% of people get into the business of drug development because of the empathy for making the world better for a lot of people. It's one of the most righteous endeavors we have — to make the life of people and the lives of their families easier."