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Cambridge Healthtech Institute’s conference on Efficient Process Chemistry focuses on early process research and development of APIs. Through podium presentations by leading experts in industry and academia, an audience-interactive panel and small group breakout discussions, attendees will share and learn best practices from one another in developing efficient ‘fit for purpose’ routes of synthesis for small molecule drug candidates. For the first time, CHI’s ‘Process Chemistry’ day-and-a-half meeting will be part of our larger World Pharma Congress multi-track event where all meeting attendees come together in the exhibit hall for refreshment and poster breaks and to expand their networking opportunities.

Day 1 | Day 2 | Process Chemistry Brochure 


Thursday, May 22

11:00 am Registration


FORMULATIONS/PROCESS CHEMISTRY SHARED PRESENTATION 

11:15 Optimizing Physical Properties by Forming Co-Crystals for Pharmaceutical Development

Dedong Wu, Ph.D., Senior Scientist, Pharmaceutical Development, AstraZeneca

The presentation will introduce pharmaceutical cocrystal approach and discuss opportunities and challenges of cocrystal applications in drug development. Cases studies from on-going projects will demonstrate how to use cocrystals to optimize important physical properties of drug candidates, including solubility, physical stability and solid-state property (e.g. melting point), thus enhancing drug developability in terms of quality, cost and time.

11:45 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own


MULTI-DISCIPLINE PROCESS R&D 

12:50 pm Chairperson’s Opening Remarks

Neelakandha S. Mani, Ph.D., Scientific Director, & Fellow, Discovery Sciences, J&J PRD

1:00 Bridging Drug Substance and Drug Product Development: the Role of Solid State Chemistry in an API Process R&D Organization

Shuang ChenShuang Chen, Ph.D., Senior Scientist, Process R&D, AbbVie, Inc.

This presentation provides an overview on the important role solid state chemistry plays throughout the development of drug candidates. Case studies are presented to highlight some of the benefits of having a dedicated solid state chemistry group within an API organization that effectively bridges between API and DP developments resulting in robust processes, manufacturing efficiencies, and improved timelines.

1:30 Investigative and Engineering Approaches in Chemical Process Development

Apurva ChaudharyApurva Chaudhary, Ph.D., Principal Fellow, Project Leader, Chemical Development, Novartis US

Enhanced process understanding based on scale-up experiences and engineering approaches have been used to understand the mechanisms of reactions and then develop new large scale processes by minimizing by-products and enhancing yields.

2:00 Incorporating Continuous Flow Technology in Exploratory Process Development

Bryan LiBryan Li, Ph.D., Associate Research Fellow, Chemical R&D, Pfizer Pharmaceutical Science

Continuous flow technology offers many advantages over batch methods, including precise control of stoichiometry, reaction time and temperature, high reproducibility, and often better reaction profile. While flow chemistry has been used widely in the fine chemicals arena, it has not been widely adopted in the pharmaceutical industry, especially in the early development stage. This presentation will discuss efforts and examples how flow technology is implemented in Pfizer’s exploratory development portfolio.

2:30 Managing and Controlling the Life Cycle of Impurities in Drug Development 

Ryan SasakiRyan Sasaki, Director, Global Strategy, ACD/Labs

Based on scale-up priorities (cost-effectiveness, safety, practicality, etc.), the synthetic route of a drug will be altered, changed, and optimized throughout the drug development cycle. Managing the life cycle of this process, the fate of relevant impurities, along with all the associated data is a major challenge. This presentation will highlight a novel approach for Impurity Resolution Management to help better manage process knowledge.

3:00 Refreshment Break in the Exhibit Hall with Poster Viewing


THINKING AHEAD IN ROUTE DEVELOPMENT 

3:45 Organo-Catalysis for Industrial Set Up: Development of a Green, Cost-Efficient Process for the Manufacture of (S)-Pregabalin

Mauro Adamo, Ph.D., Professor of Organic and Medicinal Chemistry, Centre for Synthesis of Chemical Biology (CSCB), Royal College of Surgeons in Ireland

This talk deals with the development of a new process for the manufacture of (S)-Pregabalin. The presentation will highlight the crucial elements of synthetic planning adopted and will provide an example of process development in terms of cost efficiency and E factor. We show that it is possible to redesign the synthesis of a large volume API using only cheap, readily available and recyclable catalysts that can be prepared from natural sources.

4:15 Practical Asymmetric Syntheses of Challenging Drug Candidates

Joerg DeerbergJoerg Deerberg, Ph.D., Senior Research Investigator, Chemical Development, Bristol-Myers Squibb Co.

The manufacture of Active Pharmaceutical Ingredients (APIs) of increasing structural complexity, particularly those possessing multiple centers of asymmetry, requires practical chemical tools capable of sustaining the rigors of efficiency, robustness, and isomeric purity control. This presentation will summarize recent efforts at Bristol-Myers Squibb on a series of challenging drug molecules, each of which incorporates the above design principles, resulting in concise bulk syntheses with a high degree of efficiency and stereo control.

4:45 Sponsored Presentations (Opportunities Available)

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5:15 Exploring and Optimizing Cost-Effective Route toward DPP-IV Inhibitor Compounds

Nhut DiepNhut Diep, Ph.D., Principal Scientist, Chemical Development, Forest Laboratories

This presentation describes the efforts around optimization methods for preparing DPP-IV inhibitor compounds. We will illustrate the extensive exploration synthetic strategies that were developed for cost-effective, novel streamline process, temporary protection-deprotection sequence, and scalable process toward Dutogliptin. Efforts to identify a scalable process led to the discovery of several useful transformations, including the asymmetric lithiation-boronation of the Boc-pyrrolidine that provided a single compound; the development of a streamline-telescope coupling reaction and workup which led to a robust crystallization/purification method.

5:45 Staying Off the Critical Path: Delivery of Pre-IND/Phase I API Supplies

Scott DuncanScott Duncan, Ph.D., Senior Staff Scientist, Chemical Development, Alkermes, Inc.

The first case study will illustrate an approach in which aggressive timelines were met while balancing the long term considerations of the non clinical program. The second case study will describe an approach to mitigate risk scaling up an “undeveloped” process to deliver material for IND enabling non clinical studies and then to deliver Phase I clinical supplies in the face of a “morphing” clinical program.

6:15 Close of Day

6:30-9:30pm Recommended Dinner Short Course*: Refining API Process Development for Efficiency

Instructor: Neal Anderson, Ph.D., President, Anderson Process Solutions

* Separate registration required; click on short course title below for more information



Day 1 | Day 2 | Process Chemistry Brochure 


Suggested Event Package:

May 21-22

Formulation & Drug Delivery Conference 


May 22-23

Efficient Process Chemistry Conference 


May 22

Recommended Dinner Short Course*

Refining API Process Development for Efficiency 


* Separate registration required


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