September 21, 2012
Basking Ridge, NJ
 
Small Molecules & Biologics:
Product Development Challenges of the Decade
 

On continued basis, the pharmaceutical industry must design novel and superior quality drug products and invent innovative technologies to manufacture and supply them on global basis at affordable cost. Recent scientific advances in biology and physicochemical sciences are incorporated in the design of novel delivery systems which overcome low bioavailability of poorly soluble drugs. Biologics exhibit complex structures which must be preserved during manufacture, storage, and administration of the product to maintain efficacy. Specialized drug delivery systems  are essential to deliver the biomolecules in adequate concentration to the specific sites in the cellular domains. Duplication of the biological products and getting them approved as biosimilars present an immense and uncharted challenge. Lean manufacturing pave the way to better-quality, low-cost medications. This symposium covers such evolving hot topics that will highlight the future directions of drug delivery for the biologics and small molecules. Also it provides an excellent learning opportunity to many of the product development R&D scientists in the eastern pharmaceutical belt (especially to those who won’t be able to attend AAPS, CRS, and Biotech conferences this year).

 
 
8:00 AM    Registration
 
8:30 AM    Introduction: Commitee Members and EPTM Mission
                 Elanor Pinto, EPTM Chair, Ashland
 
8:45 AM    Introduction: Symposium Theme
                 Narendra Desai, EPTM Program Chair, Pfizer Alumni
 
 
Morning Session: Small Molecules
pose challenges to formulation scientists. Successful formulation reduces the risk of manufacture with
built in product quality. Understanding of the manufacturing process is paramount to a formulation
proposal. A high quality formulation dictates the manufacturing process. It is poor practice to choose
your process then formulate accordingly. To meet the increasing need for formulation scientists to
understand the benefits of each production manufacturing process and the excipients used to achieve
optimum performance, this conference is organized to cover major pharmaceutical manufacturing
techniques such as dry blend, roller compaction, wet granulation, hot melt extrusion, liquid formulation
and etc. Successful formulation development streamlines the transformation from formulation to
production, setting guidelines for early stage formulation development.
The ultimate goal for formulation development is robust, high quality commercial production.
During the late phase development, drug product based on formulation and corresponding
manufacturing process should meet requirements from regulatory and clinical need. Furthermore, the
end drug product should take into consideration convenience and commercial production. These all
pose challenges to formulation scientists. Successful formulation reduces the risk of manufacture with
built in product quality. Understanding of the manufacturing process is paramount to a formulation
proposal. A high quality formulation dictates the manufacturing process. It is poor practice to choose
your process then formulate accordingly. To meet the increasing need for formulation scientists to
understand the benefits of each production manufacturing process and the excipients used to achieve
optimum performance, this conference is organized to cover major pharmaceutical manufacturing
techniques such as dry blend, roller compaction, wet granulation, hot melt extrusion, liquid formulation
and etc. Successful formulation development streamlines the transformation from formulation to
production, setting guidelines for early stage formulation development.
The ultimate goal for formulation development is robust, high quality commercial production.
During the late phase development, drug product based on formulation and corresponding
manufacturing process should meet requirements from regulatory and clinical need. Furthermore, the
end drug product should take into consideration convenience and commercial production. These all
pose challenges to formulation scientists. Successful formulation reduces the risk of manufacture with
built in product quality. Understanding of the manufacturing process is paramount to a formulation
proposal. A high quality formulation dictates the manufacturing process. It is poor practice to choose
your process then formulate accordingly. To meet the increasing need for formulation scientists to
understand the benefits of each production manufacturing process and the excipients used to achieve
optimum performance, this conference is organized to cover major pharmaceutical manufacturing
techniques such as dry blend, roller compaction, wet granulation, hot melt extrusion, liquid formulation

and etc. Successful formulation development streamlines the transformation from formulation to

production, setting guidelines for early stage formulation development.

 

9:00 AM    Bridging form, formation, and formulation
                 Keith Horspool, Vice President, Pharmaceutical Development, Boehringer-Ingelheim
 

9:45 AM    Approaches for the mitigation of biological and physico-chemical barriers to oral 

                 absorption of poorly soluble drug candidates
                 Shoufeng Li, Principal Fellow, Novartis 
 
10:30 AM  Coffee Break

                 Sponsors are welcome to talk about their products.

 

10:45 AM  Challenges and opportunities for oral delivery of poorly soluble drugs: Amorphous solid

                 dispersion technology based products
                 Navnit Shah, Distinguished Research Leader, Roche
 

11:30 AM  The next evolution in product design and pharmaceutical manufacturing: A paradigm shift 

                 from batch based process to continuous process
                 Jay Lakshman, Technology Platform Leader, Novartis Pharmaceuticals
 

12:15 AM  Lunch

 
 

Afternoon Session: Biologics 

 

1:30 PM    Multifunctional approaches in formulating complex protein therapeutics (Role of Excipients

                 towards Efficacy Preservation)
                 Prof.Balu Iyer, Pharmacy School, Buffalo University 
 

2:15 PM    Antibody drug conjugates: Medicinal chemistry of linkers and payloads

                 Edmund Graziani, Associate Research Fellow, Pfizer

 

3:00 PM    Coffee Break

                 Sponsors are welcome to talk about their products


3:15 PM    Novel challenges, key aspects, and potential pitfalls in vaccine formulation development

                 Jeffrey Blue, Vaccine Product Development, Merck

 

4:00 PM    Regulatory expectations and challenges for development of biosimliar products

                 Anthony S. Lubiniecki, Senior Director and Fellow, Janssen-JNJ  
 

4:45 PM    Round Table (All speakers)

 

5:30 PM    Closure

 

 

 

2012 Sponsors: