International Conference (PASAI-2026) LIVE

Ajouté : 2026-05-04

[00:00:25]Wait.

[00:00:28]One, two, three.

[00:00:47]Thank you.

[00:00:56]Yeah. Okay. I think now up your thumb.

[00:02:01]So good afternoon everyone. I hope everyone had a refreshing lunch break and our engaging poster session. As we step into next phase of the conference, we move deeper into areas that are defining modern healthcare. It gives me immense pleasure to introduce Dr. Gupat Kumar Radon as a session chair. He is currently working as a senior research scientist at the center of imuninoiology and immunotherapy and immunology co laboratories national health science and technology history. I request Dr. and Kumar are to kindly come to the stage and introduce our next honorary speaker, Professor Dr. Please come to the front seat.

[00:03:31]Now we have to start this session. So please be seated. Please be seated.

[00:03:43]Now it's my great pleasure to that welcome In this session speaker professor Dr. Dr. Junai Mary.

[00:03:56]He is the professor and deputy director of research strategy and innovation at EMU and at center for excellence center for cancer and structure research and uh institute for research development and innovation international medical university Malaysia. Professor Chun is a professor in IMU University leading the center for cancer extension research.

[00:04:30]He has more than 2,900 citation. He specialized in the translational cancer therapeutics pharmacology and pharmaceutical sciences. He also certified by Malaysian board of technology as a professional technologist in the biotechnology.

[00:04:49]He holds the PhD in the medical and health science from Malaysia and he has several international publications more than 16 years of academic career advance such experience. So, Professor Chun proceeds for your insightful lecture.

[00:05:09]>> Thank you.

[00:05:11]>> Thank you very much.

[00:05:14]Should I stand the other side or what?

[00:05:21]>> Yeah.

[00:05:22]>> Okay.

[00:05:23]>> Yeah. Okay. Thank you very much. Um, thank you. Um, thank you the organizers for the kind introductions and also thank you the organizers for the kind invitations for today's sessions. So my name is Mike. um I will be sharing the the directions on how to do cancer research uh together and how may we actually work collaboratively together. So before I start this sessions so this will be the acknowledgements from the world of peoples that actually work with us. So if you look at it I generally divide my collaborator into three category. So those who work very closely with me on the biological assay and activity that you see will be the one that mark them in or uh purple color. So the I also work very closely with a group of the synthetics and organic chemistry. So these are the people who provided me a lot of this compound that you going to see next. So those are the ones that marked there in blue color but there will be a group of them that are working on translating the research into policy into impact into changing the next generations of how we do science together. So those are the people that marked in in green color. And the last part of the group of people on the very right side is a group of researchers and also um company that share the same wisdom and interest when in our topics.

[00:06:53]So that's why there was a group of industry that also supported our work.

[00:06:57]So this work that I'm going to share with you later in a moment is comprises of work that is not just myself there will be a group of researchers who contributed. So coming to the topics that we I want to share with you. First things that I wanted to establish uh for the interest of everyone is cancer is actually a disease that's not very few that are just very single cells that we are talking about. So when we are investigating things on just a cell a lot of time we will miss the answer.

[00:07:29]That's why you look at the test tube result we call it imit result may not represent what is at the end of the day that you are seeing because cancer by nature is a heterogeneous diseases which means in the pool of the cancer they are cells that is actually respond to treatment their cells will always resistant to treatment. So with that concept in mind, our group mainly develop methods to profile them a little bit clearer so that we can model them for whatever reasons that we are interested to do that. So with that we wanted to dive into one very particular important cancer which is pancreatic cancer. Many of you will perhaps know somebody have diagnosed and most of the time they don't actually uh survive more than a year and the survival rate is actually very very low. If you can see in the chart 93% of the people don't survive more than a year. The in comparison to breast cancer and cvical cancers most of the patients actually have very very bad protosis. So with that interest in mind we started to profile all the pancreatic cancer cells.

[00:08:41]This is one of the early works that we do is when staging of pancreatic cancers was not very clear at that partial junction of time and because of that we started to use genomic way to profile all the pancreatic cancer. So this is one of the method that we do pretty much early of the 10 years ago when genomics was not very common. We already started to profile the cancer into four types.

[00:09:07]Based on this four type of the cancer we can actually design the treatments and discover the drug carrier. We are one of the groups that we started to profile cancer according to genomics. Then these methods have been continued use in the subsequent propagation.

[00:09:23]So similarly uh when I was in China during the covid time our group worked on prostate cancer. So this is one of the papers that we published to profile all the prostate cancers according to various genomics background. So through the same method you can actually understand cancers has never been one size fit all. So one treatment for one cancer it doesn't work that way and a lot of times is due to the genomic changes is so diverse. So from this chart you can tell the genomic background of the cancers can never be just as simple as just one gene one over expression. So it's actually more than that. So fast forward very recently my post talk have actually deep dive into this particular topic and we proposed that a lot of to do with how can we work together to profile genomics and pomics together and through a very comprehensive along with AI. So if you're interested to find out more this is a paper that we recently just conclude the new way of detecting cancers in the very very early stage which is now using the genomic profile.

[00:10:33]So for the interest of today's sessions I would dive into a little bit more on what we believe the way to actually settle cancer.

[00:10:42]Every one of us know that cancers happen in our body is because our body has been compromised. Because let's say you've been hit by certain thing, you will have a pain. If you a virus or bacteria come into your body, you have fever. So you have some kind of signal to tell you something is wrong. But why cancers can be sitting in the body for so long but yet doesn't give you any signal. The answers is your immune systems have been compromised. Your immune system is not able to tell you that there are something wrong that is growing inside the body. And why so is this particular chart was also able to summarize that the complex interaction between each and every of your immune cells with the cancer is actually not very unique direction. There are a lot of communication going on between the cancer and the immune cell. That's why it makes things very complicated.

[00:11:36]To make it even more complex, we also actually map up all the potential signal that can activate them and also inhibit them. And it actually very complex. It is like a life cycles like that. It started with how cancer recognize the tumor uh and the im cells and then how your immune cells have run away from cancer. So this is a cancer.

[00:12:04]If you're interested to to find out more, you can actually read out about this particular paperwork. But more important part today I wanted to share is based on this information that we established how can we tackle cancers a little bit more smartly. So what we do is in this one of our grants that we get we actually use all the patient genomic data that we can find which is from [clears throat] uh Australia's and also the world. Based on that we run multiple bioformatics method and use AI to cut a bit to eventually uh come out with one conclusion. In this study we only look at one particular marker which is your cytotoxic T cell expression. If you remember your imunology back then cytotoxic T cell is like your soldier. The soldier will go in to kill anything that is foreign. So in this particular study we realized that if your cytotoxic T cell in your body is compromised you have a worse protoxic cell. So to do that we establish the individual cell model we grow the the pancreatic cancer cells and we challenge them with cytotoxic T cell until the cell become resistant. So we developed the in-house model and that model was validated in this study and using the same model we do high throughput screening. We basically screen all FDA available drugs to see whether any drugs can be used for that and through that eventually we map out with the uh bioinformatics that we have.

[00:13:34]We propose that the hoax acceler which is the drug that used for targeted drug delivery or targeted drug treatments is can it be reverse the immune uh cells. So that is the conclusions from the papers that we made. So very fast forward. So we this is the immune uh bioinformatics that we done to profile and look for new potential target. Once we establish cytotoxicity T- cell load is a problem we further to go into whether the consistency on patient's response is there. So one way is establish that this is the hazard ratios that is confirmed high cyto cell help you to kill the cancer and we use this connectivity map methods to profile and mapping all the drugs that's available in the world and we found out that high uh hack inhibitor is one of the targets and from there we run the high throughput screening in the imit cell models that we develop and this model is we are the only one who have the model because we we we we developed the in-house model. So now we have a model who can actually map immune resistance cancer because nowadays the biggest problem that we wanted to tackle is immune therapy is the key thing but to model immune therapy is very hard.

[00:14:57]Most of the cell line that you buy from ATCC will only give you cell which is cancer. But we developed the immune cells resistance model and this model is about help us to identify which that was the cells that actually work. So in the interest of time I won't go very detailed but we at that paper conclude that the moment I gave Hack inhibitor and I give the cytotoxic T cell back the immune cells that is resistant now sensitive back to the cytotoxic T cell.

[00:15:28]So I actually don't need another molecule to kill the cancer but I just give H cell your body's H cytoxic T cell will restart and then go and kill the cancer. So that is the good things about repositioning drug by using different a more cal clever method.

[00:15:46]So we also profile the potential target that we can actually work on and eventually there are some new signals that's come up that our team is currently investigating whether we can target this particular signal to strengthen the strength.

[00:16:01]So moving forward what I wanted to explain to you guys also is sometimes we also look at different things about the profile of the cancer. Remember just now I show you at the very beginning of the client we profile cancer based on their particular target. So based on that we actually screen through all the FDA available drugs again we do the same thing to look for potential target. So we end up having five different signal.

[00:16:26]This is the five signals that may work in targeting pancreatic cancer very smartly. So to confirm what we do is we do a combination study. We add the chemo drugs and the targeted drugs together.

[00:16:38]And we this this multiple chart is to see which one it works better and in my lab we usually do this uh soft benefit study which is actually a combination study. So if you look at it if it's more green and more blue which mean at that particular concentration that we are testing it achieves synergistic.

[00:17:01]If is a red color it means that it is an antagonistic effect because when we conduct this study we actually use eight different concentration of each drug. So basically you okay it's like a matrix like that because we don't believe that synergistic or combination only work on one ratio. We actually test them on eight different concentration of drug A and eight different concentration on drug B. And because they have a different ratios of combination, we wanted to see at which concentration will be the best to achieve the smooth system. That's why you see the map is like very control. But what eventually we wanted to find as long as one concentration that give us a very very sharp clue that means that at that concentration will be the potential synthetistic that we wanted to target and most of the time it doesn't we also conclude that it doesn't work on all concentration super high concentration two drugs together it doesn't work sometime too low also don't work one too high one too low also don't work so we use this method to establish the new potential combination What is your take message is if you have a compound that of your interest you wanted to see whether it works very well with the chemo drug this way you can contact us we can help you to run this study it's very quick within a month you can complete this and very fast you will get a similar chart like this then I can tell you it works as a synergist state or adjective or a total antagonist if it's antagonist state is not the end of the story because most of the time I have actually found some drugs that entire thing. What it simply means is you cannot give the drug together. So what usually we do is we just have to space out the drug then you can potentially still keep the combination.

[00:18:50]So but this will help you to establish whether they can add together or you can space them out.

[00:18:56]So we usually will do another step once we identify the combination. What we do is we call it as a rescue experiment. So the S rescue experiment meaning that I now genetically addict the signal. So for example in this case SRC is the target. So I genetically addict the signal. So I remove the the marker or I overexpress the marker. So then if this work which means that your inhibitor will now lose it function. It's a proof of concept that if you claim that this inhibitor work in this particular mechanism. So this is the molecular methods for us to do over expressions or we do genetically knock down to actually confirm. So most of the time this is the confirmation result and this particular uh identification methods also published already you can actually pick up the study it is few years ago but what interesting is that's why from the workflows that we established we started to receive a lot of requests from our collaborators. So one of the study I wanted to highlight here is a plant extract. This plant is called the Saba snake plant. It's a plant that a lot of Malaysians will use the moment somebody diagnosed cancer. They say if I consume the juice of this plant, it will help me to cure cancer. So a lot of folks who have been talking about this plant is super wonderful. So when I test in the lab, actually I don't find any good activity at all. So at that junction of time we were lost don't know what to do but I realized that all the patients who take the juice were usually already diagnosed cancer which already started chemotherapy. So that slightly is likely is the juice is synergistic with the chemodra rather than working alone. So when we repeat the experiment with synergistic in a combination it actually work well to combine with jetabine but it doesn't work us on its own. So we eventually proceed to even identify the mechanism. So sometime it will be good to understand what the folks are using and then you can actually position your experiment according to that to find out the exact answers that you are.

[00:21:08]So we also work on a lot of uh metal complexes. So I have a friends who actually synthesize a lot of this heavy metal. This complex is futinium. So if those of you are metal complexes and things like that, you can also contact us. This is also a similar study that we done for them and we also work on novel compound. So this group of researcher is from India actually. So they constantly send me all the white powders and asking me whether you can screen for the drugs.

[00:21:37]In fact I just received a parcel with 19 molecules in my lab. So we will be starting the screening again. So what we do is usually we we we identify the potential target for them to work on and that will actually conclude where we can go. But for those of you who actually synthesize your profile, you may be worried that oh does it mean that I lost the corresponding order? I lost the IP to you. No, the answers is you will still keep your corresponding ID. Uh I authors you will still be the full IP for you. I my interest is not to take over your role. My interest is to discover what is the compound nature. So that's why all the publication you realize coming from this trap they remain as corresponding author they will take the full right I'm just supporting them because my interest is the moment they find the best compound in nanomola that's way I can actually propose to them I can work on the mechanism a bit more clever with them.

[00:22:35]So re very recently I uh we conclude one of the the study when I was in China in Shah University people talking about a more representative model is to study cancer in China we started the group a study called organoid which is a 3D culture from a patient who contain multi-ellular so they are not single syllable so whatever I show you in the past was mostly a cell line usually is bios from a patient and then they take out one cell and then this cell been grow in the patch dish and then become monollayer. So usually it's only one cell one cell type one characteristic but is a technique that we take the whole tumor out and then we dissect by keeping all the epithelial cells and all the me all the uh other cell types in there. That's why the culture is a multisellular uh suspension spoid. So it looks like a tumor on its own. So that culture methods uh is already established when I was in China. And we use that organoid as a model order to look at regeneration of cell because if your cells can grow means that they have a regen potential and the same thing apparently all the cancer organoid is the one who eventually develop the more nasty cancer. So in animal model we can also propose to look at whether they generate more tumor the tumor more aggressive and their respond to drug and couple with all the molecular target. So the a more comprehensive way to look at cancer target nowadays is to use the organoid and couple with in vitro and inivo model. But in this particular paper we also highlight each model has its limitation. So overnight it seems like the best representation but they can't grow for too long and they also have limitations that they would not have the trauma cells there. So which means immune cells is not there. So if you want to investigate immune cells clearer you need the full animal model. So the animal model in case study is still for for now because we don't have a better individual model. But if you want to screen drug or can do that overite can use for screening all the FDA drug I can immediately repurposing any of the potential drug for any particular reason. So this is a proposed new workflow for cancer study. If anyone of you is interested, we can discuss a little bit more further on that.

[00:25:11]So I stop uh conclude my question very soon. One of the things that I highlight just now was a lot of collaborations and we don't know where to talk to, who to talk to in our Malaysian pharmacy society and in July we usually host a congress and this congress usually have a lot of presentations from student from various researcher around the region. In coming July, we have the presentation from Singapore, Thailand, uh Philippines, Indonesia and of course majority will be Malaysia in that case.

[00:25:42]So if you're interested, you can actually look at it because Malaysia is one of those country. I would say that traveling food wise is affordable for Indian and you can easily find Indian food as well. So if you wanted to make collaboration, this will be perhaps the easiest one for you to look at. In 2027, we will be the local host for the FIP congress. For those of you who are pharmacist, you will know that FIP is the D organization that represent the world. So it's like the WH equivalent.

[00:26:15]In fact, FIP also advis when it come to drugs. So we will be the host in Malaysia 2027. It usually don't come to Asia to be very honest with you. Most of the time this conference is happen outside Asia and when they come it usually about 3 4,000 people from around the world. So if you want to plan your budget wise 2027 in September you can look up for this particular congress where you can actually look for potential partnership you want to visit different institution or you want to target people around the world. This could be the easiest way for you to do so. But if you want to look for this year confess this year is in Montreal, Canada, which is quite far away for most of us to be honest. With that, I thank you very much for everyone's attention and see you all when I will happy to take any questions. Thank you.

[00:27:09]>> [applause] >> Thank you professor for a nice presentation and you have done tremendous tremendously good imunological work especially you have human micro environment you have shown you also show that very cancer model so this is a wonderful opportunity to listen you for our student especially young that graduation and postgraduation. So now floor is open for questions. I think professor covered that most hot hot topics for this time because this is the cancer era is going on. So I think questions from >> so one question that study of synism was very trusting basically I wanted to just inquire whether it is synergy fun or subject >> sorry I think the echo is a bit can you repeat the question >> yeah so I wanted to ask the natural components whose synergism actually you check like whether they are behaving econistically, antagonistically or some synergism is there. So just to evaluate that uh did you use that synergy finder for us or something? Yeah, that is what >> this particular study was very interesting because actually during uh I was asked to test this because one of my friend was diagnosed breast cancer. So she was a colleague of mine in my institute. So she started to consume this particular plant where everybody telling them in Malaysia it's very good whenever you have cancer you go and take this plant then the cancer will miracle go away. So you if you talk to cancer patient you'll notice that they will try anything and everything that somebody tell them. So but she being a scientist she's a microbiologist. So she asked me can you test this? So when I test this actually at the end of the day I was quite sad to tell him that I tested we have 40 over different cancer types in my lab. So I screen every single thing even her case is breast cancer I screen everything else but I cannot find any activity. So I was about to tell her it doesn't work but that time I went back and asked her when usually people take medic she said usually it's a pain cancer patient who already started their treatment and they started to treat this without telling the doctors which is not good but they are doing it anyway and those are the people who see the effect so then I started to reflect back my model my cell model doesn't reflect the same thing which means that the cancer Cancer patients already been receiving treatment and when they take the juice is already somebody have the cancer chemo drug in their body. So I started the the synergistic study to see when I give chemo drug and the juice does it work.

[00:30:15]So eventually we found out that jidabini is the drug that actually works in the physical test. So what happened is unfortunately that the to extract the plant the phytochemist are still not able to get me the pure compound yet. So I cannot proceed further because stabilizing the plant extract it has been quite challenging since the day that happened. But at least I conclude one thing is sometimes the C plant extract works actually not on itself is actually work together with the existing drug that we already using. So that was the message that I've been telling everybody that but to be honest going into the next part is stuck because of the final chemistry people have not able to figure out how to reproduce the same extract and in the buff. Thank you. Yes.

[00:31:09]>> Hi, I'm Si from Salami. So my question is since you have worked a lot on pancreas cancer and you have shown uh some of the challenges. So you have seen lot of molecules in your experience which molecular target should be pursued as a medicine chemist if I have to for example I want to work work on pancreatic cancer. So which target should we pursue I mean for the drug design? A good question because to be honest pancreatic cancer doesn't really have a definite diagnostic marker yet.

[00:31:44]The CA19 that we use in blood test is not specific to pancreatic cancer. So that's why part of my work is going on to find a definite target that can actually define pancreatic cancer. To be honest with you, until today there wasn't a such target. But from our study we have identified two potential target that is potentially work on it but they are challenges to target them. One of them is a very super big molecule that actually work like two uh complex sticking together. So there's no way even the synthetic chemist will trying to find a pocket for them to go in. I understand where you're coming from because I actually brainstormed this with my computational chemist. So the the challenge is they haven't find a site they can actually put it in. But if I wanted to disrupt the signal, there is a way that I block one of their beacons from coming in. But that wasn't able to be very successful for now. So if you are interested, we can chat further more and whether maybe you can break through on that particular target. But the other one if you want a quick fix on on getting something um you can have a look on the paper that we release we published 2018.

[00:33:04]So this five target is kind of uh for when I analyze all the patient data and also all the sound line this five target is the one that is very prominent in por cancer. You can work on any five of them but they have a lot of commercial inhibitors that big farmer already working on. So your challenge will be you might be going into a space that you may not be able to patent. That's why some of my synthetic chemist have actually stopped because this target also most of the farmer company already protected everything that you can potentially synthesize. So I I'm screening repurposing their molecule. So that space is quite saturated if I want to be honest with you. But you can try if you are able to break through on their molecule because almost every big pharma company will have an EGFR inhibitor will have a PGK inhibitor that is already in the market. So this is the five target that works very a lot prominent in can impact cancer but for the reasons of synthetic chemist a lot of them will not find that's why they are they rather work on mine that molecule that is difficult to target if they can break that they will have a potentially new molecule coming >> yeah thank you yeah thank you Dr. for this nice s and thanks for all us for that opportunity to thank >> thank you sir for such an informative discussion now I request Dr. Deepak Kumar to fate the speaker professor Jul >> [applause] [applause] >> Thank you sir. Now I request the is torate the session chair Dr. Kumar.

[00:35:36]Please give a round of applause.

[00:35:37][applause] Thank you sir. Thank you ma'am. Where science meets purpose and innovation drives impact meaningful conversations take place. For next session we have professional Dr. Kamill Sha as a session chair. Dr. Kamill Sha is working as a director at Institute of Pharmaceutical Research GL University. Dr. Sha did his graduation from Rajiv Gandhi to Vishmidali Bopal and was awarded by Chancellor gold medal and Shrimati Kamla Dvi memorial award for securing first position in his graduation. He has qualified 2003 and 2005. He has published his research work in various international and national journal and is a reviewer of several journals. He has also written 24 chapters and five edited book and has a citation of 1500 and H index of 23. He is a member of several bodies like ABDI institutional animal ethics committee and poss. With this I welcome Dr. Sha on the dice as his session chair and request him to introduce our next speaker Dr. Kumar Gupta.

[00:37:10]>> Thank you.

[00:37:14]First of all, I must pay the thanks to the organization to provide accomplish affairs and corporate affairs.

[00:37:43]across leading multinational pharmaceutical companies such as road sign and a sought doctor speaker and leadership widely recognized for bringing the ded together with strateic policy positive in global healthcare dynamics.

[00:38:05]He has demonstrated proving leadership in global references, policy advocacy and end to end compliance across pharmaceutical, biologics, bios, medical devices, OTC products and pharmaceuticals. He has played a pivotal role in the development of key laboratory and policy reforms in India including frameworks for our fun and specific revolution and has contributed to alignment with international reference standards such as ICE US FDA Europe and Guy. In his current role as vice president at health affairs and policy at Chipla, he leads and steers strategic engagement with regulators, policy makers and multi stakeholders.

[00:38:52]With this, I would like to invite Dr. for his talk.

[00:39:26]Good afternoon everyone. Hopefully I'm audible.

[00:39:31]Uh first of all, thank you. Thank you for the introduction and uh we have seen lot of uh sessions on the uh pharmaceutical chemistry and how how researchers have been getting involved into discovering the new molecules and anti-cancer drug and finding the activities. My my session is a bit different. Uh so I'm going to talk about uh maybe maybe the relationship between uh the pharmaceutical chemistry and the regulatory affairs. So uh my my topic is from molecule to market. What is the role of AI in innovation and and what could be the regulatory strategies.

[00:40:11]So I I would like to cover up on u the drug discovery and development process role of regulatory authorities how how role is evolving and then the role of regulatory affairs say the pharmaceutical industry in this future perspective and uh and integration of AI into the pharmaceutical industry.

[00:40:34]So uh maybe I would like to start my presentation with simple business process flow. So uh because of the science and technology uh we we first of all identify the opportunities and then once we identify the opportunity and then we develop the product and once we develop the product we start manufacturing and uh distribution and uh between science and technology it's mainly the customer need who is going to play uh the key role in terms of uh in terms of the discovery of the molecule like uh maybe I maybe like to ask a general question from the audience that uh currently which farmer company is valued very highly or or top most valued. Can can anyone tell me which farmer company is highly valued at this point in time?

[00:41:29]It's uh either in highly or not. It's because of because of the buzz around the anti-obesity drug and uh the anti-obesity market. So that's why the science and technology and the customer need the customer need is everyone want to be slim. Everyone want to have certain medicine certain magic pill which will be given and and that person become known obese and that person comes to a normal life. So that's the customer need and depending on the customer need uh the companies identify the opportunity develop the product manufacture and distribute them. So, so that's a that's a very common slide showing showing the strong relationship between the business process flow that how science and technology is getting evolved depending on the customer needs.

[00:42:17]So uh from discovery where drugs come from so so we have a lot of sources drugs can come from plant, fish, animal can be synthesized in the laboratory.

[00:42:29]There can be different processes like extraction, fermentation and synthesis etc. So this is this is the way to go. Uh can you make it? Can you patent it? Is [laughter] it active in within vivo? Is it drug life? Is it safe? Is it going to be an effective drug? Is there a market?

[00:42:54]So while while discovery the focus is towards the safety and and in the previous sessions we talked about the lead optimization and the lead identification of a molecule. So so that's the drug discovery and artificial intelligence nowadays is playing a critical role in terms of identifying the targets in terms of identifying the receptors where drug can bind more effectively and uh that's that's the first step which is called as discovery and from discovery we move to development. Is it safe? Is it efficacious? Can it be outlicicensed?

[00:43:27]Will it beat the competition? And finally, the product get launched.

[00:43:32]So, so that's the basic pro from discovery to development. The milestones are really significant.

[00:43:40]States and costs are really high. Risk is also high because drugs are getting testing in few months and potential rewards are also greater. uh and regulatory oversight is becoming one of one of the critical factor in terms of the drug development.

[00:43:58]uh moving on uh to the various phases of the drug development. uh it start from the lab to basic research to pre-clinical to clinical testing to marketing and if we look into regulatory has a critical role almost in each and every stages whether this is IND whether this is NDA whether it is subsequent new drug regulatory is playing a critical role in in all of these so uh regulatory milestones moving from preclinical to clinical phase filing an IND molecule moving from phase 2 to phase three filing a NDA product launch post approval commitments everywhere everywhere regulatory play critical role and if I talk about the role of regulatory authorities uh the mission of the regulatory authority is to promote and promote the to promote and protect the public health by giving good quality safe and efficacious medicine. Monitor the product for continued safety after they are in use and to help the public so that they get accurate science-based information needed to improve the health.

[00:45:02]So how do a regulatory authority give an approval in the current scenario when the diseases like life-threatening diseases, unmet medical need, rare disease, so many things are present, it's always a risk public benefit analysis ratio bas basis which a drug truck drug is get uh getting approval from from the health authority. It is being said that if aspirin is discovered today maybe the whole process may not be as simpler as it was at that particular point in time because this is a drug having multiple effects into the body.

[00:45:35]So the laboratory oversight overall removal process is becoming more and more stringed day by day.

[00:45:43]So fundamental principle is same the truck should be having good quality, safe and efficacious.

[00:45:50]Uh in terms of uh the assessment of post by the regulatory authorities, regulatory authorities look into a lot of factors.

[00:46:01]Is the disease resulting in having heavy human loss? What are the risk involved?

[00:46:06]Is the safety profile adequate? Do the benefit to the society outweigh the risk to the patient? And if we look into revelatory cost, revelatory cost for developing a drug is nowadays really very very high because it include cost of drug, it include personal cost, expert cost, inspection cost, cost of review and resubmission, cost of resilience etc etc. Like we talked about in the previous session that CO2 inhibitors like roof or celipox causing serious side effects like heart attacks. If AI can be in use if more of things can be done rigorously through regulatory AI processes then then maybe certain uh side effects of heart attacks can can be avoided.

[00:46:55]So again this is another important slide which talks about the regulatory decision. Uh regulatory decision benefit the population at large benefit that outweight the risk do not cause an outcry like like we talk about ox 2 inhibitor or we we talk about hip implants which which cause which which has caused heavy poisoning like cyosis or metallosis into the body. So, so these decisions sometimes cause a strong outcry while regulator regulator give the approval. So, so the regulatory decisions are something which are benefiting the public at large and support you to the industry while protecting the patient and uh and regulator has to take very accurate and judgmental calls in terms of deciding about these monies.

[00:47:46]Okay.

[00:47:47]Maybe I will move on to uh the challenges challenges in terms of uh the regulatory perspective that uh currently either the regulator or the industry faces. This is regulatory scientists need to keep up with the rapid advancing technologies.

[00:48:04]More sophisticated products are coming.

[00:48:07]More sophisticated technologies are coming. As I talk about the coming time is of innovation. will come in of biological stem cell based therapies, biosimler. So, so these therapies and these technologies are really really complex. They they are not simple one. So, these technologies will translate into product with new complexity and risk new may request everyone to please be quiet.

[00:48:38]uh and uh these uh these diseases are emerging and new public health threats are emerging like we have seen in the co is something which is which has emerged as a public health threat and uh causes an outcry. Uh international commerce is growing, consumer information is increasing, uh the customer is becoming more and more sophisticated day by day.

[00:49:03]So these are these are few of the challenges which regulator or or industry faces almost each and every day. Priorities uh is basically the risk management better consumer information post marketing safety as I talked about if if there are side effects then then certain molecules can be withdrawn from the market and uh and and health agency may ask to recall the product from the market. There are many examples where many molecules has been uh asked to reform and effective regulation and strong workforce is something which is which is one of the key priority for almost each and every country and uh regulator is working quite strongly on this.

[00:49:47]Uh now coming on to what is the scope of regulatory affairs? What does the RA department do? Regulatory affairs department is involved in almost each and every stage either that is a basic research pharmacology toxicology, biostatistics, bioharmaceutical project management everywhere regulatory affairs is involved. So what does RA department do? It's involved in regulatory strategy, meeting with regulatory bodies, preparing the dosier in terms of clinical trial applications, NTA drug masterile and doing all the correspondence with the regulatory authorities.

[00:50:22]uh role of regulatory affairs during preclinical phase after clinical either it's a pre INT meeting or IND submission safety reporting preparing NDAs post approval commitments at every step regulatory affairs department is important so this is again uh filing of dosier updates to CMC data preclinical studies clinical studies meeting with the regulators every at every stage regulatory affairs department is involved Uh these are the different type of regulatory submissions starting from the investigational new drug to new drug to ANDA to drug must file to clinical trial application. Uh in Europe it may be called as marketing authorization application or a applications. Then then uh the periodic updates being born in terms of the variation renewal annual report safety updates etc etc. Compliance is one of the critical aspect and compliance is of three type GLP, GMP and GCP and this is applicable throughout the development of the drug and non-consequence non-compliance may lead to the serious consequences.

[00:51:35]Now I'm moving on to where is the industry headed? What is happening locally and globally? And if I talk about Indian pharmaceutical industry, it's a knowledge based industry. India is exporting to almost all countries with a major share in the related market. India is rated world single producer and top exporter of generic drug. Every third consumed in the world is made in India. Three out of global 10 fastest growing generic companies are Indian.

[00:52:04]But when we are talking about the coming time when we are talking about moving from volume to value moving towards the innovation we are looking forward for very strong R&D in terms of biologicals biosynthelers cell and gene therapies drug device combinations stem cells because that is going to be the future.

[00:52:29]So India is now among the top five farmer emerging market globally but uh uh front runner in wide range of uh specialties. We have done quite well in terms of the complex truck. USFD approvals speak about the stringent knobs followed by the Indian companies.

[00:52:47]But uh major uh uh again many procurement agencies for developing country develop over value uh overwhelming on India. 70 to 90% of essential medicines comes from India.

[00:53:03]Most of the tenders of UNICEF uh and all the global agencies like PEPA are being taken care by India. But as we talk about as AI is growing, as innovation is growing and as we are looking into the Indian scenario, Indian government is coming up with a lot of scheme like bioarm shi scheme and prep seed scheme where there is a lot of lot of focus towards the biological. So maybe that's that's the right time to focus on the innovation and the research and regulatory is going to play a very critical role in terms of giving out these improvements.

[00:53:37]And if I look into challenges for the Indian pharmaceutical industry, preparatory compliances is one of the barrier. Warning letters being issued by US FDA, that's another challenge. And I talked a lot about innovation, biological, medical therapies, novel uh novel therapies. These are the future.

[00:53:55]Other key challenge is skilled resources and mindset. So if we look into that sort of innovation we we we really need young brilliant mind who can work around the complex R&D of biologicals the complex R&D of stem cell etc. Another key challenge is a lot of mergers and acquisitions are happening.

[00:54:18]Uh another key challenge with regard to the global industry is declining productivity, competitive pressure, reducing drug approval because regulations are becoming more and more stringent, development costs are increasing, increase in clinical trial period due to tighter drug safety repolation, higher safe higher development cost and and other key challenge is that post marketing surveillance is becoming more and more stronger due to which there are a lot of product recalls and withdrawals from the market.

[00:54:50]So another another key challenge is rapid hype in prices, overall economic slowdown, rising government deficit, reduction in healthcare budget, high prescription drug, aging population, administrative cost, spending on chronic diseases is really increases increasing day by day.

[00:55:10]uh companies forced to reduce the prices because of because of either the competition or because of making the drug more affordable and accessible. So so these are the key challenges and this is I try to give an overview of regulatory affairs. What exactly the regulatory affairs whatever chemistry of synthesis being happened in the lab? How do these drug get converted and from lab they uh these drugs reach to the market. So I will try to cover all of these aspects. With that, I would like to end up my presentation and I'm more than happy to take any questions.

[00:55:44]Thank you so much.

[00:55:47][applause] Now the station of any question.

[00:56:27]Let us see all the Each of the micro market I USF US they will give it now based on the person or getting every trial that was taken year is either completely wrong or maybe completes where it's medical us very point of view and that's how they are reducing the time for depending on the severity of the disease of the designation being sold.

[00:58:37]>> Thank you sir for brainstorming session.

[00:58:40]I would now like to request professor Dr. Kamill Sha to felicitate our speaker Dr. Vipul Kumar Gupta.

[00:58:50]Sure.

[00:59:00][applause] Thank you.

[00:59:21]Thank you sir. I now request dean our session chair professor Dr. Please give a round of applause.

[00:59:30][applause] >> [applause] >> Thank you sir. Thank you.

[00:59:59]So for next session we have Dr. Kala as currently working as associate professor pharmacy right now. With this I would like to invite Dr. Kalita assessment chair and introduce our next speaker Dr. invite this lecture request.

[01:00:35]So everyone I hope you all are here with your lunch session and you have heard so many voices. So may I have the privilege to introduce Dr. So thank you so much for organizing team for giving me this opportunity to chair the sessions. I have the privilege to introduce Dr. Arshad Guru. So he's currently serving as head of biability and biogrants division at Sun Pharmaceuticals India. He holds a PhD degree in phocinetics and bring over 30 years of extensive expertise in his field. His professional strength include deep knowledge of GCP or GP guidelines growth protocol designing, bioharmaceutical evaluation, clinical operations, regulated bioanalysis for phocetics as well as phicodnamic endpoint studies supporting and NDA 505 findings. So as a test facility manager, Dr. Guru ensures GLP compliance in conduct of preclinical studies over his distinguished career. He has successfully navigated more than 100 regulatory inspections throughout and being a regulatory inspection across the region. It's a big achievement. Congratulations sir. So he has authored as well as co-authored more than 100 scientific articles published in leading international journals.

[01:02:20]Beyond his scientific contributions, Dr. Khu is also an accomplished author of two books, echoes of experience, 30 insights from life's journey and perceivable interactions, both of which have been well received by the readers globally. With this, I would like to invite Dr. Arshan Kuru on the DS.

[01:02:44]>> Good evening. Am I audible?

[01:02:47]>> Am I audible?

[01:02:48]>> Yes sir.

[01:02:50]I have some questions for you. Some questions.

[01:02:54]And I have some toffes also for you.

[01:02:57]First question.

[01:02:59]And for that one, what's the average number of words which we speak per minute?

[01:03:11]What's the average number of words which we speak per minute? A normal human being. Any guesses?

[01:03:20]Who's like 80?

[01:03:23]>> 60 to 70. Anyone else?

[01:03:26]>> Anyone else?

[01:03:30]>> Anyone?

[01:03:36]Anyone?

[01:03:39]Okay. Next question. How many words can a person's brain process? A normal human being can process how many words per minute?

[01:03:52]Any guesses?

[01:03:53]Any guesses?

[01:03:57]>> Not depending on average. How many?

[01:04:01]How many?

[01:04:04]30 40.

[01:04:06]A normal human being can speak on an average 100 to 150 words per minute. A normal human being can process from 300 to 800 words per minute. Now it means if I'm a very good speaker, I can speak maximum on an average 150 words per minute. And if a person is not a very good processor, his brain is not very well established. He or she can still process 400 words minimum for a minute.

[01:04:34]So it means there's a gap between the person who speaks and the person who prosters and between that gaps what happens?

[01:05:04]24 hours.

[01:05:11]Any thoughts?

[01:05:16]Anyone?

[01:05:24]1,000 per 24 hours. We will get 70,000 thoughts. 70,000 Not a single person was interested in the presentation and the presentation from Dr. C was very nice and my presentation is not as better as Dr. So I'm sure you will not be interested in my presentation also. I'm so sorry. Your organizers have actually put their efforts to make this beautiful beautiful conference for all of you and not a single one I was again and again looking at not a single student was interested in this presentation. I don't know why why do you know motivation speaker I have two books authored two books she has mentioned name of the books. Can anyone mention name of one book which she mentioned?

[01:06:41]So if [clears throat] you cannot remember name of one book which she mentioned as speaker is coming then why should I give presentation to all?

[01:06:50]Why human at least.

[01:07:29]What is that?

[01:07:32]In the interest of time, let me just summarize what I'm supposed to say because I have come here all your professors, all your administrators, they have called me and then they will tell me that in five or 10 minutes so that you can leave Facebook, YouTube, >> Instagram.

[01:08:16]Do you know what the difference between information and knowledge? Information is what you get through all these social media. Knowledge is what you are supposed to get from these presentations. You people are densy interested in information and not knowledge. Knowledge but I will give you some information what I was supposed to say during my uh during my presentation.

[01:08:39]In my presentation, I was supposed to say what is genetic development, what is in development, stages of genetic development and stages of innovative development and what are the differences and what is the role of homogenetics in that drug development starting from preclinical to clinical phase one phase 2 phase three and postpartic what scientists and clinicics plays a role in the drug development. Then in the second session I was going to tell you what AI play how AI plays a role in drug development. Like for example if I am doing a phopathic study or bioent study which you might have read if you are in pharmacy. So in bio study we prepare a protocol and then we then we do clinical dosing. We can collect samples. We analyze those samples using liquid chrome mask specimetometry. Then we finalize those construction data and then we do form handicolation.

[01:09:38]So this AI is helping us in different ways like for prepare protocols then putting inclusion exclusion criterias or even it is also helping us in in predicting the results. It is also helping us in finalizing the conclusions drafting justifications. That's what I was supposed to tell you in the presentation. So I shared that presentation with Dr. Khaled and I think Miss Anchel. So whenever you have that interest in my presentation go through that presentation that will give you an inside and I'm I'm ready here to take any questions related to related to industry wherein you can apply inocinetics with information of course with no knowledge. Any questions related to scientist? Any questions?

[01:10:59]Sir has coffees also sir. I think you have to also who are asking question may be offered those. I have I have Yes sir.

[01:11:50]There are much My name is the M to the student.

[01:12:22]So what I'm what I'm saying is not that we are only working on industry or academics only working on drug development. There are multiple institutes but industry also and problem last year actually I put this chapter in my book also I was invited by MT international as guest of honor and our DCJ who is Dr. Dr. He was invited as chief of chief guest and he gave his answer.

[01:13:15]So we have to actually become innovative. If you ask me that where are we in terms of industry, where are we as an innovation innovative company?

[01:13:28]I agree with you. So with knowledge you can become innovative.

[01:13:44]any other questions.

[01:13:49]So when a prophecy there's a problem and psych problem is that when a person speaks again with 150 words and then a person is crossing 400 words has to engage with people as soon as you leave the room you forget 80% and as soon as 24 hours are complete.

[01:14:26]When you engage with someone either as a parent or as a friend or as a brother or or as a colleague when you interact with someone whether you engage with someone then that 10% can step to mind otherwise 60% or 90% engagement with each other in communication is very important. Any other questions before we close?

[01:15:02]Any other questions?

[01:15:23]of special thank you so much and it was nice here I came here for the first time in Mangal hope so to come again as I mentioned I'm a trainer also I I train people in decision making and about in self motivation and I'm also writing a book on self motivation Thank you. Thank you. Thank you so much, sir. [applause] I think now we are able to recognize him throughout. He actually visited and interacted with each and every one of you. That's the best part of it. And now no one is sleeping also and they're not talking among each other. That's the biggest challenge otherwise. So, thank you so much, sir. and the slides that he's mentioning. So we'll be circulating them and of course you can refer to his books motivational books definitely everyone talk about subject but to stay motivated again it's very much important we need someone who make us feel motivated that way to whatever our passion is so just to achieve that thank you so much sir for guiding our students also and I hope the students enjoyed your session a lot I think this was short crispy and uh the most effective one what I can say thank you so much sir thank >> [applause] >> Once again thank you sir for sharing your valuable insights and most important for engaging our audience in such a beautiful way. Thank you. Now I would like to request Dr. Kalpna Nagpar to facilicate our speaker Dr. Ashit Kuru.

[01:17:24]>> [applause] >> Thank you sir. Thank you ma'am. Now I request Dean SM to kindly fistate our session chair Dr. Ka Nagpal as a token of our gratitude and appreciation.

[01:18:08]Thank you ma'am. As innovation in in pharmacy is not just about discovering drugs but about delivering better lives.

[01:18:17]Continuing with the momentum of this insightful technical session, we now move ahead to our next plinary lecture.

[01:18:23]I'm pleased to share that we have Dr. Nid sat here who is working as an associate professor at DIT University Dhadami with over 17 years of experience in teaching research and innovation as session chair. I would like to request sir to please raise the ties and introduce our next plenary speaker professor Dr. Luke Ka.

[01:18:46]Please give a round of applause.

[01:18:49][applause] First of all, I would like to thank organizer for inviting and giving me this opportunity speaker of the soed by professor Dr. Qin.

[01:19:20]So professor TS Dr. Din is the head of the department of pharmaceutical technology and industry at the faculty of pharmacy university of cyber ja. He holds a bachelor of pharmacy master of science in pharmaceutical technology and PhD from University says Malaysia with prior experience in community and industrial pharmacy. His expertise response pharmaceutical R&D particularly in the area of orally disintegrating doses form nano formulation including myel transferogone marinosone and polyelerolyte complexation cosmosics and bioequivalence studies. He has published over 150 scientific article and book chapter and secured research funding exceeding RF 1 million. His innovative research has earned multiple international award including at the mte, ITX and IPIX.

[01:20:32]Professor New is a charted scientist UK and a registered professional technologist in Malaysia. He has delivered invited talks across Asia and supervised numerous undergraduate and post-graduate research project. In addition to his academic role, he actively contribute to professional development and community engagement and was honored with the vice chancellor research excellent award in 2025. With this I would like to invite professor Dr. I win for Thank you.

[01:21:17]>> Right. Uh good afternoon everyone. Okay.

[01:21:20]Uh my name is Leil. I'm from Malaysia.

[01:21:22]Uh I come to India for 3 days but I have been asked by the many time to finish my testing. Testing right is better now.

[01:21:47]All right. Uh yeah, I come to India for 3 days and I've been reminded to finish up my presentation in 20 [laughter] minutes. So I will grab this opportunity in 30 minutes to share my experience in this research. Okay. My topic of this presentation is actually on probiotics and we put it into a tin fl and use it as a oral health supplement. So the title of my presentation is an oral disposable FL platform for advancing oral microbio modulation through bio probiotic delivery.

[01:22:19]Okay. Basically I'm from this university you see is actually just located around 30 minutes from from KL center. So we established in 20 2005 and now it's almost 20 years. So basically we start with the courses like uh the medical sciences, pharmacy and slowly then we expand to um business admin uh art and others.

[01:22:47]All right. So this is a brief introduction about myself. I'm a pharmacist from graduated from USF science Malaysian and my area of research is actually in the area of drug delivery systems. So I work a lot on those advanced moral drug dosage form such as chocolate. Uh anyone like chocolate? You like chocolate? I believe that even though you are shy to raise your hand but some of you might like chocolate. We use chocolate as a delivery systems to deliver drug to the patients and we also probably flip. Hey, how many of you do not like tablet or capsule because you feel it hard to swallow or feel choking?

[01:23:25]I I did some maybe a geriatric or B patients they might have a fear of choking. So we for instead of giving tablet or capsules dosis form we formulate into thin fl like ODM or dispersible fl and others.

[01:23:40]Okay. So [clears throat] today I'm going to talk about this uh part of this topic which is the oral health. Oral health is actually a global art mat. So if you look at um the statistics here actually there are many peoples that they are suffering from oral health disease such as a caris such as the teeth loss and others and one of the most important thing is that oral health does not stand alone oral health actually affecting one's confidence when a person has carries or having certain bad smell in the mouth it's hard for this person to confidently stand in front and then talk to people because he feel like he's shy he or she feel like shy [laughter] to open the mouth if they if if he's suffering from bad smell or pureis or any gum diseases. Right? So this is one of the area that always uh un uh the is unmet and this is the stages of uh the tooth decays. On the most left hand side is the healthy tooth. Then you will see that erosion start to happen. Okay. uh in the handl and then going to