Upcoming Seminar & Speaking Engagement Schedule

CRS Industry Roundtable: Current Trends in Bioavailability Enhancing Technologies
Location: Washington State Convention Center, Room 6A
Date & Time: July 20, 2016, 8:00am-9:30am
Moderator: David Lyon, Bend Research
Speakers:
-Bryan Knox, Pharmatek
-Derek Hennecke, Xcelience
-Patrick Marsac, University of Kentucky
-Jon Miller, Vertex Pharmaceuticals
-John Morris, AbbVie
-Colin Pouton, Monash University, Australia
-David Vodak, Bend Research/Capsugel

Summary:

More than 60% of the compounds in pharmaceutical pipelines today are considered to be poorly bioavailable due to slow dissolution rate or poor solubility.  This has led to a need for using increasingly sophisticated delivery technologies.  These technologies range from particle size reduction technology aimed at increasing dissolution rates to amorphous dispersions and lipid delivery technologies.

Expert panel members will participate from the pharmaceutical, contract research, market intelligence industries and academia.  During this roundtable, we will share viewpoints on bioavailability enhancing technologies and how to rationally choose the best technology.

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Past Seminars

Topic: Product Development Strategies for Poorly Soluble Compounds– Adding Value with Spray Dried Dispersion
Location: Pharmatek, 7330 Carroll Rd., Suite 200, San Diego, CA 92121
Date & Time: June 23, 2016, 12:00pm-5:30pm
Speakers:
-Meredith Perry, Scientist, Pharmatek
-Nathan Barksdale, Scientist, Pharmatek
-Jonathan Scrafford, Process Engineer, Pharmatek

Summary:
What delivery technology is 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. Presentations focus on strategies for oral drugs and include technologies for poorly soluble compounds with an emphasis on spray dried dispersions.


Key Learning Objectives:

  • What Data is Necessary to Make Confident Development Decisions
  • How to Design a Data-Driven Formulation Development Program
  • Options for Difficult-to-Formulate Molecules
  • 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

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Topic: Creating a Quality Culture
Date & Time:
Thursday, May 19, 2016, 10:00am to 11:00am 
Event: Patient Safety: The Pharmaceutical Industry’s Challenges and Steps toward Ensuring Drug Quality
Location: Baltimore, MD
SpeakersTim Scott, President of Pharmatek

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Topic: Skin-Applied Products: From Concept to Approvals in San Diego
Date & Time:
Wednesday, April 27, 2016, 8:00am to 10:00am 
Location: BIOCOM- 10996 Torreyana Rd., Suite 200, San Diego, CA 92121
SpeakersPieter Dorrestein (UCSD), Kevin Rosenthal (Pharmatek), Avadhesh Kushwaha (Tioga Research), Dan Piacquadio (Therapeutics Inc), John Newsam (Tioga Research)

Summary:
Why are dermatology programs so much in favor with investors? Does it really take less time to advance a topical drug program through clinical trials and approvals? What has happened in formulation science that has created such opportunities for new topical products? Why would I favor a transdermal mode of administration over others? What is special about the skill sets required to advance a skin-applied product program?

Hear answers to these questions. Learn how skin-applied product challenges are being addressed. Be prepared to quiz our expert panel on which classes of therapeutics lend themselves best to a skin-applied format, when a transdermal delivery route is preferred, and on how simple or complex a topical or transdermal development program can be.

San Diego is developing as a major international center for skin-directed activities. We are fortunate to have a constellation of CROs and CMOs that can advance a topical drug program from concept all the way through Phase 2 and 3 clinical trials. The nature of the San Diego CRO community is such that it encourages inter-company cooperation. A client can then benefit from ‘best of breed’ strengths being brought to bear, while avoiding discontinuities that can arise elsewhere when technology transfer is needed. And these local strengths extend also to non-pharmaceutical beauty and hygiene products.

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Topic: Formulation Development of Small Molecules: Preclinical to Clinical
Date & Time:
Tuesday, April 26, 2016, 11:00am to 4:30pm 
Event: Vancouver PBSS Workshop
Location: Floral Hall, Vandusen Gardens, Oak Street at 37th
SpeakersAnthony Boey (CDRD), Bryan Knox (Pharmatek), Joe Lubach (Genentech)

Key Topics Include: This workshop will focus on practical aspects of the formulation of small molecules from early stage preclinical research to clinical development Challenges with poorly soluble compounds

  • Challenges with poorly soluble compounds
  • A review of various formulation technologies, their advantages and disadvantages
  • Preclinical formulation strategies
  • Requirements for preparation of suitable formulations
  • Clinical formulation strategies
  • Changes in formulation from Phase 1 to Phase 3
  • Standard clinical formulations
  • QC issues
  • Case studies

The workshop is designed to discuss “common practices”, the theoretical basis for these practices, practical ideas for implementation and limitations associated with formulation development.

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Topic: CMO SPOTLIGHT- Drive a Culture of Quality at Your CMO

Date & Time: April 20, 2016, 9:15am-10:00am
Event: 6th CMO Quality Oversight & Risk Management Summit 
Location: Sheraton Boston Hotel, Boston, MA
SpeakerTimothy Scott, President,  Pharmatek

Key Topics Include:

  • Recognize quality as the most important factor at your CMO
  • Drive employee engagement for enhanced quality and production
  • Implement an effective internal CMO management structure

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Topic: Comply with EMA Guidelines by Setting Health-Based Exposure Limits for Use in Risk Identification in Manufacturing in Shared Facilities
Date & Time:
April 20, 2016, 4:45pm-5:30pm
Event: 6th CMO Quality Oversight & Risk Management Summit 
Location: Sheraton Boston Hotel, Boston, MA
SpeakerJenn Samore, QA Associate III,  Pharmatek

Key Topics Include:Avoid cross-contamination of different medicinal products to prevent risk to patient populations

  • Avoid cross-contamination of different medicinal products to prevent risk to patient populations
  • Manage the presence of contaminants according to the level of risk
  • Analyze variables related to determining the level of health risk posed by cross-contamination
  • Explore to which CMOs the new regulations may apply

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Topic: UPCEA 2016 Annual Post-Conference- Panel Discussion on Program Innovation Excursion
Location: UCSD- 9500 Gilman Dr., La Jolla, CA 92037
Date & Time: April 9, 2016, 2:00pm-8:00pm
Panelists:
-Timothy Scott, President  Pharmatek
-Sean Barr, Sr. VP of Economic Development, San Diego Regional Economic Development Council
-Rosibel Ochoa, Executive Director, von Liebig Entrepreneur ism Center, Jacob School of Engineering, UCSD
-Paul Ruben, Assoc. Vice Chancellor for Innovation & Technology Commercialization, UCSD

Moderator:
-Mary Walshok, Assoc. Vice Chancellor of Public Programs & the Dean of Extension, UCSD

Summary:
Cities around the globe are struggling with how to grow 21st century technologies, businesses and talent. Economic research makes clear that universities play a pivotal role in that process. Nowhere is this truer than in San Diego. Over a 50 year period, the Torrey Pines Mesa Research Park has developed an array of research institutions anchored by University of California, San Diego, which have contributed to the development of numerous science-based clusters creating 140,000 new high-wage jobs and changing the face of the regional economy.

In this unique UPCEA Annual Conference post-conference excursion, attendees will take a deep dive into this science-based innovation ecosystem. Hosted by a prestigious panel of experts and moderated by Dr. Mary Walshok, Associate Vice Chancellor of Public Programs and the Dean of Extended Studies at University of California, San Diego, attendees will then explore how research and educational institutions are evaluating the demands of this sector and developing state-of-the-art programs to meet the knowledge and skill requirements for the workforce that fuels San Diego’s innovative economy.

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Topic: Product Development Strategies for Poorly Soluble Compounds– Adding Value with Spray Dried Dispersion
Location: Hilton Short Hills, 41 John F Kennedy Pkwy, Short Hills, NJ 07078
Date & Time: March 15, 2016, 12:00pm-5:30pm
Speakers:
-Bryan Knox, Sr. Director of Pharmaceutics,  Pharmatek
-Nathan Barksdale, Scientist, Pharmatek
-Jonathan Scrafford, Process Engineer, Pharmatek

Summary:
What delivery technology is 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. Presentations focus on strategies for oral drugs and include technologies for poorly soluble compounds with an emphasis on spray dried dispersions.
Key Learning Objectives:

  • What Data is Necessary to Make Confident Development Decisions
  • How to Design a Data-Driven Formulation Development Program
  • Options for Difficult-to-Formulate Molecules
  • 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

Click here for details

Pharmatek’s President, Tim Scott will speak on two panels at the Outsourced Pharma West Conference
Location: Hyatt Regency San Francisco Airport
Date & Time: November 3rd at 11:00am & November 4th at 3:00pm
Panel Topics:

November 3rd discussion topic-Where in the world do I find my outsourcing partner?: Starting the search, Creating your vetting process (culture, price, reliability) & Understanding that the best partner may be next door or across the globe
November 4th discussion topic-Exploring the future of outsourcing: Exploring LifeCycle Outsourcing™ as the future of outsourcing & Debating other bold predictions from our panelists/audience

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Topic: Product Development Strategies for Poorly Soluble Compounds– Adding Value with Spray Dried Dispersions
Location: Crowne Plaza Foster City, 1221 Chess Dr., Foster City, CA
Date & Time: October 21, 2015, 12:30pm-6:00pm
Speakers:
-Jeff Bibbs, PhD., CEO & CSO, Pharmatek
-Nathan Barksdale, Scientist, Pharmatek
-Jonathan Scrafford, Process Engineer, Pharmatek

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Past Seminars

Topic: Early Phase Drug Product Strategies
Location: Harlem Biospace, 423 W. 127th St. New York, NY 10027
Date & Time: June 15, 2015, 6:00pm-7:00pm
Speaker: Brent Moody, Field Engineer, Pharmatek

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Topic: Formulation and Route of Administration
Location:
 9th Annual Drug Discovery for Neurodegeneration Conference: An Intensive Course on Translating Research into Drugs
Date & Time: March 2, 2015, 2:15 pm
Speaker: Bryan Knox, Sr. Director, Pharmaceutics, Pharmatek

Click here for details.

Topic: Best Practices for Working Together with a Sponsor to Achieve Seamless Execution of Product Development
Location:
 5th CMO Quality Oversight & Risk Management Summit
Date & Time: April 25, 2015, 3:45 pm – 4:30 pm
Speaker: Timothy Scott, President, Pharmatek

Click here for details.

Topic: Make It Simple, But Significant: Data Driven Formulation Development
Date & Time:
 October 22, 2014, 6:00 p.m.-8:00 p.m.

Speakers:
-Bryan Knox, Sr. Dir. of Pharmaceutics at Pharmatek
-Vivek Kadambi, V.P. of Nonclinical Development at Blueprint Medicines
-Frank Waligora, Director of CMC at Curis
-Ahmad Hashash, Sr. Scientist at Ironwood Pharmaceuticals
-Matthew Frizzle, Manager of Business Development at Alphora Research

Summary:
What formulation strategy is best for your goals? With fewer Phase I candidates making it to proof of concept, it’s important to have the appropriate strategy in place for your early phase development. Pharmatek’s Bryan Knox will discuss how reaching first-in-human clinical studies quickly is often critical, especially for companies with limited budgets or investor milestones tied to this step.

A phase-appropriate approach to development will get you from the bench to the clinic quickly. Of equal importance is the creation of a formulation that will give your candidate the best chance at success. From bioavailability enhancement technologies for insoluble compounds to API-in-a-capsule, this seminar covers multiple development strategies.

Key Learning Objectives:
-Why understanding different formulation strategies is important to the long-term success of your compound.
-Strategies for oral and injectable drugs.
-Strategies for poorly soluble compounds & controlled release.

Topic: Drug Development Risk Assessment- CMC Considerations
Date & Time: October 10 2013
Speakers: Bryan Knox, Sr. Director of Pharmaceutics, Pharmatek

Summary:
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 Copy of this Seminar

Topic: Early Phase Formulation Strategies
Date & Time: September 30, 2013

Speakers:
-Lisa Caralli, Dir. of Pharmaceutics, Pharmatek
-Brent Moody, Technical Sales Representative

Summary:
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 is 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 Copy of this Seminar

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