Pharmatek: Fundamentals of Peptide Formulation Develoopment & GMP Manufacturing

Join Pharmatek for a Complimentary Half Day Seminar…

Product Development Strategies for Poorly Soluble Compounds: Adding Value with Spray Dried Dispersions
We are pleased to invite you to this complementary half day seminar dinner focused on strategies for poorly soluble compounds, with an emphasis on spray drying. Lunch and cocktails and appetizers will be served.

About the Seminar
What drug delivery technology will be right for your drug candidate?  Join us as we review several early phase formulation approaches for small molecule drug candidates. Discussion will include methods for developing a sound, phase-appropriate formulation with scientifically supportable data to help progress development to the next phase in a timely and cost-efficient manner. The presentation focuses on strategies for oral drugs and includes technologies for poorly soluble compounds with an emphasis on spray dried dispersions. Speakers will cover case studies and discuss solutions to overcome formulation challenges.

Date: October 21, 2015

Time: 12:00pm – 6:00pm

Cost: No Charge

Location:
Crowne Plaza — Foster City Hotel
1221 Chess Dr.
Foster City, CA 94404

Speakers:
Jeff Bibbs, PhD, CEO Pharmatek

Nathan Barksdale, Scientist, Pharmatek

Jon Scrafford, Process Engineer III, Pharmatek

 

If you would like to learn more about the seminar or to register to attend, please click the button below.

   

Topics include:

  • What Data is Necessary to Make Confident Development Decisions
  • How to Design a Data-Driven Formulation Development Program
  • Options for Difficult to Formulate Molecules
  • Case Studies of Successful Data-Driven Formulations.
  • Parameters that indicate amorphous dispersions and spray dried dispersions are an optimal formulation approach.
  • Best practices for formulation screening and evaluation of stability, performance, and manufacturability of spray dried dispersions.
  • Fundamentals of the spray drying process
  • Critical quality attributes & keys to successful spray drying
  • Closed vs open loop spray drying systems
  • Attributes and benefits of different spray dryer nozzles
  • Spray drying scale up from bench to pilot GMP and process improvements during scale-up
  • Downstream processing equipment for spray dried intermediate

Meet with Pharmatek in Orlando
Visit our booth #632. To schedule a meeting with a Pharmatek representative at the show, contact:

Collin Burger: cburger@pharmatek.com
858.805.6383 x325

About the Speakers

Jeffrey A. Bibbs, PhD is co-founder and CEO of Pharmatek. He has a broad background in preclinical drug development, medicinal chemistry and physical organic chemistry. Dr. Bibbs is an instructor at University of California , San Diego Extension, teaching classes in Drug Development and Formulation Development. He is also a co-founder of Diakron Pharmaceuticals, a pharmaceutical company focused on cardiovascular disease. Dr. Bibbs earned his Ph.D. from the University of Kansas and was a postdoctoral fellow at Texas A&M and The Scripps Research Institute. He worked in medicinal chemistry and drug development for 10 years at Amylin Pharmaceuticals prior to founding Pharmatek.

Nathan Barksdale is a Scientist at Pharmatek.  Mr. Barksdale has over 10 years of experience in the pharmaceutical development and manufacturing industry working with Small Molecules & Peptides.  He has broad background in preclinical through clinical drug development and GMP manufacturing.    He possesses a strong knowledge base in oral formulation development and manufacturing, complex process trains, and highly-potent & cytotoxic compounds.  Nathan received his Bachelor of Science in Pharmacological Chemistry from the University of California, San Diego.   In his free time, Nathan is an avid outdoorsman and enjoys spending time on family camping trips with his wife Gretchen and two children Gracie &George.

Jon Scrafford is a Pharmaceutical Process Engineer III and the Process Engineering Team Leader at Pharmatek. Jon has more than seven years of experience in the pharmaceutical industry, ranging from preclinical to commercial scale GMP manufacturing. At Pharmatek, he specializes in solid-oral formulation and process troubleshooting, scale-up and optimization, including cytotoxic compounds, granulation techniques and spray drying. Prior to joining Pharmatek, Jon worked as a Process Engineer rat Genzyme in Boston in commercial-scale cell culture/protein purification manufacturing. He received Bachelor of Science in Chemical Engineering with a minor in Business, from Northeastern University in Boston. In his free time, Jon is a world traveler, an ardent sports fan, and an avid reader.

Strategies for Poorly Soluble Compounds at Pharmatek
As the number of poorly soluble compounds increases, conventional formulation strategies may no longer provide acceptable bioavailability and targeted clinical proles. Scientists may need to utilize advanced formulation technologies to overcome these issues. Pharmatek oers several strategies to meet the challenge of poor solubility. Our range of royalty-free technologies to address poor solubility include:

• Amorphous Dispersions
• Particle Size Reduction
• Lipid Delivery
• Complexation
• Hot Melt Granulations