Visualization

Challenges and selection

I am a formulation scientist working in pharmaceutical company. My job is to develop and  formulate a various Oral dosage forms (Tablets, Capsules) and scaling it up to commercial  scale. I started as a fresher with good background of pharmacokinetics mingled with  formulation technology understanding. Recently one project given to me along with my senior  colleague to formulate a generic product for a reference product or innovator product. The  innovator product cost is around 23 lakhs per 120 tablets. Our goal or objective is to produce  the bioequivalent product similar to Innovator or Reference product and reduce the cost of  tablet as minimum as possible so that it can be reached to maximum number of people at lower  cost (affordability). Before joining the organization my collogue is already working on the  same project for last one year and failed to meet the bioequivalence (BE) criteria due to its high  variable nature. I read in detail regarding the project and understood reasons behind the failure  of BE studies with my pharmacokinetic background. So I faced so many issues in explaining  the factors responsible for BE failure and unable to explain in clear and understandable manner  to my colleague and peer members. Finally, visualization tool learned from this course helped  me a lot. This tool helped me a lot in providing the exact insights and ideas which I have  through diagrammatic representation, flow charts, different invitro tools to identify the root  cause in failure of BE and suggested some more invitro tools to match the BE criteria.

Application

During project review meeting with senior colleagues, explained some of my insights to meet  the BE criteria and made them understand all experiments need to perform ,development of   the new invitro tools to make the product bring to market at lower cost with matching BE  criteria. I wrote all the reformulation experiments. But on the next day colleagues are in a  sceptical mode to perform the reformulation experiments and also upon development of new  invitro tools to identify the root cause.

Then I thought that there is some communication gap between me and my senior colleagues  because the colleagues all are skilled up but unable to receive the information mentioned orally  to them. This process continued for two weeks and unable to get the positive outcome.

Well, after attending the course I thought of applying the visualization tool. I started  considering fellow senior scientists as my first customer than the final patients who are in need  of product, so that if they understand properly, then a better version of the formulation could  be designed, and the BE criteria will be met and finally it will be commercialized and released  into the market at a cheaper and affordable price.

So, next day I asked the free time of senior scientist and made various flow charts making him  understand different approaches of formulation design combining different ingredients or  excipients. Made one by one invitro tool to identify the exact root cause of previous failure of  BE Study. Below is the some of the images of the visualization that I used to make them to  understand:

While making him understand even I got various ideas from my colleague to even sharpen up  the ideas to formulate and manufacture the Bioequivalent product. So, for me visualization tool  has many benefits. First, it makes people understand better what you want to convey and gives  you various new ideas to deal with the problem.

Insights and Approach

Well, what an output it was when we saw the results of invitro (better invitro results in  comparison to failed BE formulation). It reflected exactly what I wanted and moreover had  elements that gave a wow factor in reducing the cost of BE product. The senior colleagues  could also add their experiences as they also understood what the concept is about as I made  them visualize the concepts of reformulation. Now, my company has a separate process in  between stages of formulation development to identify the best strategy to identify the product  which matches with the innovator in terms of safety and efficacy. We have discussions on the  BE Studies and created some platform to identify the similar line of products to bring the  essential medicines to market at lower cost so that it can be reaches at every corner of world.  In future, I will likely use this visualization tools further to identify more complex generic  molecules to match clinical BE criteria by systematically identifying the invitro tools and  techniques.


Visualization Challenges and selection I am a formulation scientist working in pharmaceutical company . My job is to develop and formulate a various Oral dosage forms ( Tablets , Capsules ) and scaling it up to commercial scale . I started as a fresher with good background of pharmacokinetics mingled with formulation technology understanding . Recently one project given to me along with my senior colleague to formulate a generic product for a reference product or innovator product . The innovator product cost is around 23 lakhs per 120 tablets . Our goal or objective is to produce the bioequivalent product similar to Innovator or Reference product and reduce the cost of tablet as minimum as possible so that it can be reached to maximum number of people at lower cost ( affordability ) . Before joining the organization my collogue is already working on the same project for last one year and failed to meet the bioequivalence ( BE ) criteria due to its high variable nature . I read in detail regarding the project and understood reasons behind the failure of BE studies with my pharmacokinetic background . So I faced so many issues in explaining the factors responsible for BE failure and unable to explain in clear and understandable manner to my colleague and peer members . Finally , visualization tool learned from this course helped me a lot . This tool helped me a lot in providing the exact insights and ideas which I have through diagrammatic representation , flow charts , different invitro tools to identify the root cause in failure of BE and suggested some more invitro tools to match the BE criteria . Application During project review meeting with senior colleagues , explained some of my insights to meet the BE criteria and made them understand all experiments need to perform , development of the new invitro tools to make the product bring to market at lower cost with matching BE criteria . I wrote all the reformulation experiments . But on the next day colleagues are in a sceptical mode to perform the reformulation experiments and also upon development of new invitro tools to identify the root cause . Then I thought that there is some communication gap between me and my senior colleagues because the colleagues all are skilled up but unable to receive the information mentioned orally to them . This process continued for two weeks and unable to get the positive outcome . Well , after attending the course I thought of applying the visualization tool . I started considering fellow senior scientists as my first customer than the final patients who are in need of product , so that if they understand properly , then a better version of the formulation could be designed , and the BE criteria will be met and finally it will be commercialized and released into the market at a cheaper and affordable price . So , next day I asked the free time of senior scientist and made various flow charts making him understand different approaches of formulation design combining different ingredients or excipients . Made one by one invitro tool to identify the exact root cause of previous failure of BE Study . Below is the some of the images of the visualization that I used to make them to understand : While making him understand even I got various ideas from my colleague to even sharpen up the ideas to formulate and manufacture the Bioequivalent product . So , for me visualization tool has many benefits . First , it makes people understand better what you want to convey and gives you various new ideas to deal with the problem . Insights and Approach Well , what an output it was when we saw the results of invitro ( better invitro results in comparison to failed BE formulation ) . It reflected exactly what I wanted and moreover had elements that gave a wow factor in reducing the cost of BE product . The senior colleagues could also add their experiences as they also understood what the concept is about as I made them visualize the concepts of reformulation . Now , my company has a separate process in between stages of formulation development to identify the best strategy to identify the product which matches with the innovator in terms of safety and efficacy . We have discussions on the BE Studies and created some platform to identify the similar line of products to bring the essential medicines to market at lower cost so that it can be reaches at every corner of world . In future , I will likely use this visualization tools further to identify more complex generic molecules to match clinical BE criteria by systematically identifying the invitro tools and techniques .