Bench to Clinic – Preclinical & First-in-Man Drug Development Strategies

Date: January 18, 2017
Time: 10:00 am PDT
Speakers: Dr. Pingyun (P.Y.) Chen, PhD, Director, Early Development at Catalent, Nathan Barksdale, Senior Formulation Scientist at Catalent & Anthony Leone, Director, Preformulation at Merck


Every year, hundreds of drug candidates are abandoned during preclinical testing studies. Physical characterization, salt selection and polymorph screening, and formulation become key enabling technologies for ensuring continued development. Preclinical-stage formulations drive meaningful efficacy and toxicity assessment by maximizing exposure. Once the compound passes preclinical assessment, focus shifts to choosing the right human dosage form.

For most early phase companies, reaching first-in-man quickly is critical, especially for companies with limited budgets or investor milestones tied to this step. Of equal importance is the company’s choice of formulation strategy. A poorly formulated drug can lead to negative clinical data, severely tripping up development plans.

Over-development at this phase, however, can be just as detrimental when timelines and resources are tight. Therefore, an early phase development strategy should start with a thoughtful analysis of the drug substance, pre-formulation data, desired clinical outcomes, and the strategic goals of the company.

Join industry experts to discuss several factors that impact early phase development and clinical success. Discussion will include case studies and 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.

About the Speakers

Dr. P.Y. Chen serves as the director, early development at Catalent Pharma Solutions. He began his pharmaceutical career as a research investigator in pharmaceutical development at GlaxoWellcome in 1999. After spending one year as a principal research scientist at Eli Lilly in 2004, he returned to GlaxoSmithKline to co-lead the solid form sciences team to provide global salt and polymorph screening and selection support for drug candidates from discovery through commercialization. He joined Catalent Pharma Solutions as the manager of the Optiform TM Technologies in 2010. Dr. Chen has given multiple presentations as an invited speaker in scientific conferences, co-authored over 40 publications and book chapters, and named as a co-inventor on multiple patents.

Nathan Barksdale is a Scientist at Catalent San Diego, Catalent’s early stage development site for preclinical through phase II dosage form development and GMP manufacturing. Mr. Barksdale has over 10 years of experience in the pharmaceutical development and manufacturing industry working with Small Molecules & Peptides. He has a 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.

Anthony Leone is the Director of Preformulation at Merck.

Part 1: Product Development Strategies for Poorly Soluble Compounds: Adding Value with Spray Dried Dispersion

Date: March 3, 2016
Time: 11:00 am PDT
Speakers: Bryan Knox, Sr. Director of Pharmaceutics at Pharmatek & Nathan Barksdale, Senior Formulation Scientist at Pharmatek


Data Driven Formulation Development

Bryan Knox, Senior Director of Pharmaceutics, Pharmatek
As NCEs coming out of discovery present solubility challenges, often companies do not have the expertise to identify the most appropriate formulations to support toxicology and clinical studies.  Regrettably, very rarely does the first solubility-enabling formulation solve dosing requirements. Fortunately, there are several key compound characteristics that can help direct formulation develop and formulation selection. Pharmatek recommends taking an agnostic approach therefore relying on relevant data and formulation expertise to make these key unbiased decisions. A compound’s physiochemical characteristics as well as dosing requirements should be carefully assessed while multiple formulation types are considered, including API-in-a-capsule, simple blends, liquids, spray-dried dispersions and melt granulations, to determine the best path forward.  This presentation will cover multiple dosing strategies and methods to determine which technology is best suited for your needs. 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


Spray Dried Dispersion Formulation Development for Early Phase Clinical Studies

Nathan Barksdale, Senior Scientist, Pharmatek
Current estimates indicate that more than 70% of new chemical entities require solubility enhancement to achieve plasma exposure. Amorphous dispersion technology is a growing approach to improve solubility and in vitro dissolution rate of these insoluble compounds by providing a supersaturated concentration of drug, which often translates to rapid in vivo solubility and improved bioavailability. A common technology for preparing these amorphous dispersions is spray drying. This presentation will focus on the fundamentals of developing and handling spray-dried dispersions, including stability assessment, in-vitro performance, and downstream manufacturability. Topics will include:

  • 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.
    • Pre-Formulation solvent solubility screening and stability assessment.
    • Rapid polymer screening for solubility enhancement.
    • Screening of selected polymers and drug loads for physical and chemical stability.
    • Excipient compatibility testing.
    • In-vitro and in-vivo  formulation screening

About the Speakers

Bryan Knox is the Senior Director of Pharmaceutics at Pharmatek, a contract dosage form development and GMP manufacturing organization. He has a broad background in preclinical and clinical drug development and manufacturing of small molecules and peptides. Mr. Knox’ nineteen years of pharmaceutical industry experience include managing hundreds of oral formulation and analytical development projects, controlled release and amorphous dispersion formulation development, process scale up and technology transfer. He earned his MBA from the University of California, San Diego’s Rady School of Management and his bachelor of science in biochemistry from the University of California, San Diego.

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.

Part 2: Spray Dried Dispersion Process Development

Date: March 10, 2016
Time: 11:00 am PDT
Speaker: Jon Scrafford, Manager of Process Engineering at Pharmatek


Amorphous dispersions prepared by spray drying are a growing approach to improving the solubility and dissolution rate of many poorly soluble compounds. Bench-scale spray-drying units, like the Buchi Mini Spray Dyer B-290, are utilized for feasibility studies and in some cases being used as GMP production units for high-value low-volume drugs. As the product moves toward larger batch requirements, scale up to larger spray dryers is required. This presentation will focus on spray drying process development and will cover spray-drying equipment and scale-up of from the bench to pilot scale. Come and compare your notes for scale with us. Topics will include:

  • 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 nozzles
  • Process improvements during scale up
  • Typical processing equipment for spray dried intermediate

About the Speaker

Jon Scrafford is the Manager of Process Engineering  at Pharmatek. Jon has more than eight years of experience in the pharmaceutical industry, ranging from preclinical to commercial scale GMP manufacturing. At Pharmatek, he leads a team specializing 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.

Click Here for the Recorded Presentation

Key Considerations for Companies Outsourcing their Clinical Packaging & Distribution Needs

Date: July 22nd, 2015
Time: 11:00 am PDT
Speaker: Mark E. Paiz, Founder & President of Sherpa Clinical Packaging
Moderator: Kevin Rosenthal, Director of Manufacturing Business Operations, Pharmatek


Clinical packaging and distribution are seen as necessary elements in strategic planning, and are key components of ensuring the successful start and completion of a clinical program. Effective management of the clinical supply chain is critical.

From virtual biotech companies to large pharmaceutical companies, outsourcing is a key consideration in clinical packaging and distribution. Outsourcing is a valuable strategy for companies of all sizes and capabilities, and it should be entered into for reasons specific to a company’s requirements. This includes using objective information as well as other criteria that may be less tangible, but just as critical to success. This presentation will include an overview of critical aspects and challenges of supply chain management and a case study of a real world trial. Topics covered will include:

  • A summary of packaging configurations, including bottling, blistering, carding and kitting.
  • Factors affecting clinical packaging design, such as blinding and randomization
  • Global distribution considerations including cold chain logistics and IVRS/IWRS (IxRS) Systems
  • An overview of drug accountability requirements including returns, reconciliation and destruction

About the Speaker

Mark Paiz has over 20 years of experience in building and operating successful organizations. As a senior executive he has been responsible for leading commercial, manufacturing, supply chain, quality and product development functions. He founded Sherpa Clinical Packaging in 2010 and has built the business into a successful CTM services organization. Previously, he served as President and COO of Arbor Vita Corporation, a biotech company focused on therapeutic and diagnostic product development. Mark also spent 10 years at Quidel Corporation, a leading point-of care diagnostic company where he served as COO. His experience also includes multiple product development and operational roles for Medtronic, Hybritech and Loral/Ford Aerospace. Mr. Paiz received his B.S. degree in Engineering from the University of Colorado, his M.B.A. from West Coast University and General Manager Certification from Harvard Business School.

Click Here For The Recorded Presentation

Drug Development Risk Assessment-CMC Considerations

October 10th, 2013
Speakers: Bryan Knox, Sr. Director of Pharmaceutics, Pharmatek


Each drug candidate is unique and carries with it its own development challenges. Additionally, each company has their own resource constraints, such as budget, timeline and experience. These challenges and constraints contribute to the overall development program risk. To avoid costly delays and mistakes, each program must be evaluated and assessed for its specific risks.

Drug Development Risk Assessment-CMC Considerations provides a quantitative approach to assessing risk in oral drug development programs with respect to Chemistry, Manufacturing and Controls (CMC). Based on the evaluation of hundreds of different drug candidates, the webinar will help you evaluate risk associated with your drug development project. We will present methods for developing a dashboard of critical areas as well as strategies to mitigate some of the risk going forward.

Key Learning Objectives:

-Understanding the risks that each drug development program poses

-Evaluating and assessing specific risk categories

-How to strategize and plan for risks in your drug program

Click Here To Download A Recording of the Webinar

Early Phase Formulation Strategies

September 30, 2013
Speakers: Brent Moody-Technical Sales Representative, Pharmatek
Lisa Caralli-Director of Pharmaceutics, Pharmatek


What Formulation Strategy is Best for Your Goals? Fewer Phase I candidates making it to proof of concept, demonstrates the importance of having an appropriate strategy in place for your early phase development. Pharmatek’s Lisa Caralli & Brent Moody will discuss how reaching first-in-man clinical studies quickly is often critical, especially for companies with limited budgets or investor milestones tied to this step. Of equal importance is the creation of a formulation that will give the candidate the best chance at success. A phase-appropriate approach to development will get you from the bench to the clinic quickly. From bioavailability enhancement technologies for insoluble compounds to API-in-a-capsule, this webinar covers the best development strategies, that match the physiochemical characteristics of your compound with your corporate goals, clinical timelines and development budget. There will be a live Q&A with Lisa and Brent at the end of the presentation, a great opportunity for you to put forward any questions or thoughts that you may have.

Key Learning Objectives:

-Understanding how different formulation strategies are important in the future success of your compound.

-Strategies for oral and injectable drugs

-Strategies for poorly soluble compounds & controlled release

Click Here To Download A Recording of the Webinar

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