Meeting 5:30 p.m. to 9:00 p.m.
50 Park Plaza, Boston, MA 02116
General Meeting format
Sponsors can begin setting up at 4:45 p.m.
Registration/cocktails/social hour with sponsors: 5:30 - 6:30 p.m.
Dinner starts approximately 6:30 p.m.
Introductions and presentations begin at approx. 7:00 p.m.
Presentations and Speakers
Messenger RNA: A Novel Therapeutic Modality
Örn Almarsson, Moderna
Until recently, contemplation of messenger RNA (mRNA) as a therapeutic platform has been eschewed, owing to challenges in oligonucleotide delivery and perceived shortcomings of mRNA as a drug. These limitations include unavoidably large molecular size, instability and immunogenicity. Significant advances in oligonucleotide delivery as well as mRNA chemistry to ameliorate immune stimulation have been realized over the past decade to enable mRNA therapeutic opportunities. Given these advances, mRNA is positioned to become an important new therapeutic modality with potential for acceleration in drug development.
Örn Almarsson is head of formulations at Moderna, responsible for nanoparticle formulations in discovery and early development, since 2013. Prior to Moderna he was Vice President of Pharmaceutical R&D at Alkermes, head of Early Drug Product Development in J&J, and a senior scientific leader at Transform Pharmaceuticals (acquired by J&J in 2005). Örn began his industry career at Merck Research Laboratories in Pharmaceutical R&D. He received his B.Sc. degree in chemistry from the University of Iceland and a Ph.D. in bio-organic chemistry in Prof. TC Bruice's lab at University of California at Santa Barbara. Prior to moving into industry, he conducted post-doctoral research in biotechnology at MIT with Prof. Alexander Klibanov.
Enhanced Formulation Decision-Making In Early Phase Clinical Trials For Parenteral Products
Dr. Crowley from Quotient Sciences
The presentation will describe the principles and applications of Translational Pharmaceutics: an R&D platform integrating formulation development, real-time adaptive GMP manufacturing and clinical testing. This model has been applied to all dosage forms including sterile injectable products to accelerate initiation and completion of clinical trials. Products are manufactured at small-scale immediately prior to dosing thereby reducing early CMC investments. Within-trial formulation adjustments can be made in response to emerging clinical data to maximize study outcomes. The benefits of this flexible model will be illustrated with case studies including assessing new route of administration, and optimizing long-acting injectable products.
Dr. Crowley is Senior Scientific Director at Quotient Sciences, responsible for the project design of integrated CMC and clinical development programs using Translational Pharmaceutics. He has 16 years of pharma experience in CMC roles ranging from early-stage preformulation through to formulation development and scale-up. His expertise is in selecting and optimizing drug delivery systems based on the physicochemical and biopharmaceutics properties of the active ingredient. Dr. Crowley received his Ph.D. in pharmaceutics from the University of Bradford U.K. in 1999, then completed a post-doc at the University of Wisconsin-Madison in 2001 before working in both biotech (AnorMED) and CDMO (Catalent) sectors, and joining Quotient in 2013.
Director, Drug Product Manufacturing
• PDA Members: $115
• PDA Student Members: $10
• PDA Retired Members: $10
• Unemployed Members: $10
• Non-Members: $135
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Register online by 12:00 Noon,
Friday, Jan. 12th
Late registrations will be accepted after noon on January 12th on a
• Late Registration is $145 for all.
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Late registration payment will be accepted at the door. You can now pay for late registration with your credit card.
NEPDA Upcoming events
March 14th, 2018 Dinner Meeting and tour at Millipore Sigma, Topic: "Future Trends in Manufacturing"
May 16th, 2018 Dinner Meeting
September 12th, 2018 Dinner Meeting
November 14th, 2018 Dinner Meeting