Charting the Right Path to First in Man

Tuesday, October 23 2012
8:00 am – 1:30 pm

Event Inquiries

Lauren O’Bray (lauren.obray@patheon.com) or Lauren Perna (lauren.perna@massbio.org)

Location: MassBio, 300 Technology Square, 8th Floor, Cambridge, MA

Our team of expert pharmaceutical scientists is pleased to invite you to a complimentary seminar titled, Charting the Right Path to First in Man. The seminar will be held on Tuesday, October 23rd in Cambridge, MA.

 

Click here to register for this FREE seminar.

 

About This Seminar:

 

Reaching first in man studies is a critical milestone in the drug development process. However, the road to a successful IND submission is long and complex, with many important decision points along the way that can have long-term effects on the development of the molecule. Whether you are faced with a bioavailability issues, financial constraints, or pressure to meet accelerated deadlines, having a well-designed development plan for your molecule can make the difference between success and failure.

 

During this seminar, presented by MassBio and Patheon, you will hear case studies and analysis from industry leading experts on Regulatory Strategies for IND Submission, Analytical Method Development for preclinical and IND submissions, and Pre-formulation and Formulation Development for IND enablement for both sterile and non-sterile products. You will also hear a detailed case study about an insoluble compound that has successfully navigated through preclinical development to First in Man, and lessons learned from that experience. These presentations and interactive Q&A sessions will provide you with insight into how to speed your molecule to First in Man studies through optimal formulation, analytical and regulatory strategies.

 

Presenters:

  • John McCarty, President, McCarty Pharma Consultants Inc
  • Jason Vaughn, Ph.D., Scientific Director, Patheon
  • John Koleng, R.Ph, Ph.D., Adjunct Assistance Professor at the University of Texas at Austin, Partner at AlphaVekto, LLC and Associate at Regulatory Compliance Initiatives
  • Jim Wright, Ph.D., Chief Scientific Officer, Bind Biosciences

Registration is free. To register, click here.

Light breakfast and lunch will be served.

 

Agenda:   

 

8:00-8:30 AM Registration & Breakfast   

 

8:30-8:45 AM Introduction  

  •  Anil Kane, Ph.D., MBA, Patheon

8:45-9:30 AM Filing an IND for Early Clinical Studies: What You Need to Have for First-in-Man Studies  

  •  John McCarty, President, McCarty Pharma Consultants Inc

9:30-10:15 AM Clinical Success Through Stepwise Preformulation and Formulation Development

  • John Koleng, R.Ph, Ph.D., Adjunct Assistance Professor at the University of Texas at Austin, Partner at AlphaVektor, LLC and Associate at Regulatory Compliance Initiatives

10:15-10:30 AM Break

 

10:30-11:15 AM Successful Analytical Method Development for Preclinical Assessment and IND Enablement

  • Jason Vaughn, Ph.D., Scientific Director, Patheon

11:15 AM -12:00 PM A Case Study of Taking an Insoluble Compound into Man

  • Jim Wright, Ph.D., Chief Scientific Officer, Bind Biosciences

12:00-12:10 PM Closing Remarks

 

12:10-1:30 PM Networking Lunch

 

 

Biographies:

John McCarty has held R&D management positions at Key Pharmaceuticals, Schering Plough, and Pharmavene (acquired by Shire Pharmaceuticals) and is the founder of the international consulting firm McCarty Pharma Consultants Inc. He was also VP for Formulation Sciences and Drug Delivery at Azopharma Product Development Group. John is known for his broad expertise in the development of all major dosage forms and is a contributor to industrial publications such as Tablet and Capsules and American Pharmaceutical Review. He is an inventor on numerous US and foreign patents. He earned Bachelor degrees in Microbiology and Chemistry from Florida Atlantic University in Boca Raton, FL.

Jason M. Vaughn, Ph.D.  has 12 years of pharmaceutical development experience.  He spent several years at PharmaForm LLC in various positions including Associate Director of Analytical and Formulation Development, Director of Operations and eventually Vice President of Operations.   He then joined DPT Laboratories as Director of Formulation Development where he led a team that developed formulations for liquids and semisolids. Following this, he joined Enavail LLC as Director of Research.  In 2012, Jason joined Patheon as Director of Scientific Affairs in the Cincinnati facility. He received a B.S. in Pharmacy and a Ph.D. in Pharmaceutics from the University of Texas at Austin. 

John J. Koleng, Ph.D. co-founded and served as COO/VP Industrial Operations at PharmaForm, a CDMO focused on novel drug delivery systems, before founding AlphaVektor, a drug delivery technology and development consultancy. He is a Principal with Regulatory Compliance Initiatives.  Over the past 17 years, he has guided and assisted numerous life-science clients in the development of their technology enriched/enabled products, delivery systems, and processes for various indications. John’s drug product development experience ranges from nano-dose tablets and abuse deterrent systems to liquid-filled capsules, hot melt extruded dosage forms, and transdermals. He has published scientific research articles on topics including hot melt extrusion, pressurized meter dose inhalation, and aqueous film coating. John received a B.S. in Pharmacy and a Ph.D. in Pharmaceutics from the University of Texas at Austin where he holds an Adjunct Assistant Professor appointment.

Jim Wright, Ph.D. is Chief Scientific Officer at BIND Biosciences. Prior to joining BIND Biosciences, Dr. Wright was Vice President of Development at Infinity Pharmaceuticals. Before joining Infinity, he was Vice President of Pharmaceutical Development at Millennium Pharmaceuticals. Earlier, he was Senior Vice President of Development at Alkermes and Distinguished Scientist at Boehringer Ingelheim Pharmaceuticals. During his long career, Dr. Wright has established a track record of success in developing and commercializing multiple drug modalities including products based on traditional dosage forms such as Viramune®, for treatment of HIV-1 infection, and on breakthrough drug delivery platforms, such as Risperdal Consta®, a long-acting injectable form of the antipsychotic risperidone. Additionally, Dr. Wright teaches at the University of Wisconsin as an Adjunct Professor. Dr. Wright received his Ph.D. in Pharmacy from the University of Wisconsin and B.A. degrees in Biology and Chemistry from the University of California, Santa Barbara

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