The Panel Discussion on “Pharma and Biopharma Industries in India: Challenges and Opportunities in Innovative Drug Discovery and Development” was conducted as a part of the concluding session of the virtual workshop on “Drug Discovery and Development” from 15th March to 4th April 2021 by the Federation of Asian Biotech Associations (FABA) (biofaba.org.in), the Science Gurus (sciencegurus.org) and the University of Hyderabad (uohyd.ac.in). The workshop participants included undergraduate students, postgraduates, research and postdoctoral scholars, and research scientists from universities, research institutions and Pharma/biotech industries across India, Bangladesh, Israel and Iran. The highlights of the workshop were the exceptional speakers who participated from both India and the US and presented breakthrough advances in the field of drug discovery and development.
Panelists :
1. Anand Anandkumar (CEO, Bugworks)
2. Dr. Tanjore Balganesh (President, GangaGen)
3. Dr.Srikar Raman (VP and Head R&D, Levim Biotech)
4. Dr. Manish Diwan (Head – Strategy Partnership & Entrepreneurship Development, BIRAC)
5. Dr. Nishith Tyagi (Director, AI and Data Science,
Novartis)
Moderator: Dr. Uday Saxena, ReaGene Innovations
Other Contributors:
Professor P. Reddanna (University of Hyderabad)
Dr. Ajith Kamath (Advisor Pandorum Technologies) and
Dr. Bindu Madhava Reddy (Assistant Professor, University of Hyderabad)
Q1: India has done very well in development of generic and biosimilars. However, we have not produced an innovation-based first in class medicine yet. Please name one reason for this and a possible solution
Anand:
Innovation takes funds and risk-taking ability but Indian Biopharma still does not have that ecosystem yet. Secondly the supply of validated targets that can be used in drug discovery come from Academia and Industry collaboration in the USA, but no such activity is prevalent in India. This is a big gap in Indian Innovation ecosystem. Things are changing and will get better soon but, we are not there yet.
Nishith
The risk-taking ecosystem is not there in India. Secondly, academia normally leads the way in innovative science, where India is still lagging. Disease biology and medical science towards innovation is lacking in India and unless we work more in this area we will lag behind.
Balganesh
We tend to work in silos, there is hardly any cross disciplinary interaction between biology and say, chemistry. This is important for translational and product research. The second aspect is that we do not have clinicians participate in the innovation process, either in understanding disease biology or in epidemiology. The third point is that our best brains are post-doctoral candidates in the US and tend to stay there.
Srikar
There is no dearth of funding in India – our generics and biosimilar sales are huge and we are the third largest economy in the world. Also, our young talent is very good, but we do not have experienced people in the Indian regulatory system or guidelines to assess and support innovative approaches to treat diseases. We need feedback from them and need positive but critical advice from them. We have to be patient and things will improve and the biopharma will grow.
Manish
The status of first in class discovery in India is pathetic. Preclinical discovery and clinical development form two pillars of innovation. We do not have much experience in clinical development – as seen by our product pipeline, hardly few molecules are in clinical development. We need larger numbers in clinical development. The experience that we have acquired in biosimilar space is excellent and clinical development of novel drugs should follow a similar pathway. We can expect to see many large international pharma companies set up shop here and that will help us.
Q2: Is our academic training good enough to support Innovative and translational science?
Anand:
Few years back when we looked at the PhD talent pool for industry it was not very good, but quality is improving. our scientists have to think about data, ability to comprehend and use data. They have to think like a startup and think in a big picture and explore getting training in data sciences as a tool.
Nishith:
We have excellent QA scientists and they all come from academia but still not ready for the future. We should be offering integrated courses that involve computer training very early. Secondly, medical institutions have to be involved to provide a clinical perspective. Finally, AI/ML skills need to be included in the drug discovery process to absorb the vast amount of information that is out there. So, students need to be trained in AI/ML as well as exposure medical sciences.
Balganesh:
We are not there yet – but we can get there. Late 80’s there was no value attached to patents, but slowly patenting is improving. But its only being done as a mandatory activity without understanding the importance. This has to change. Secondly, in the past there were a handful of Institutions that trained talent pools very well and the number is still small. One element is rotational training of PhDs across discipline like it is done in the USA. Finally, we need to have academia go work at the industry and create a highway of knowledge sharing.
Srikar
PhD trains you to do research, it’s an enabling tool but not means to innovation excellence. What is needed is a leader/mentor who can see the big picture and bring everything together and think uniquely. It’s not just PhD but focus has to be on training in innovation skills.
Manish
Twenty years ago I did a postdoc in South Korea. It was eye opening because every faculty there had links with industry and had a spin off. Similarly, in Japan, PI who did not have industry collaboration was looked down upon. This is something we need to have in Indian academies, without which quality exposure to innovation will not be there. We have very few students/PIs in India that venture into new areas but spend their lifetime working on the same problem. However newer and younger faculty are aggressive and are more collaborative and students from such labs are better prepared. The Government now tends to fund multidisciplinary and industry connected projects.
Dr. Reddanna
A number of academic institutions in the country with highly qualified faculty and excellent infrastructure are working on various biomedical problems but they have very limited interactions with industry due to lack of push from academia and pull from industry. Secondly, no institution has medical schools attached, which is critical for innovation research. This is a major challenge in pushing biomedical ideas into products. Industry in India is risk averse and thus have very limited opportunities for fresh PhDs for innovative research. In contrast, in the IT industry, in view of plenty of opportunities, they recruit and train fresh students and make a productive workforce.. BIRAC has helped a large number of start-ups and that’s where young scientists are getting training. But startups are not funded deep and VC funding is needed for further development of their innovative products However, Venture financing ecosystem is yet to evolve in India.
Anand
We need a triangle of three sections to come together – regulatory, funding and we need to hear from Indian big pharma why there is a lack of interest in innovation.
Dr. Bindu M. Reddy
Clinicians do not have an opportunity to interact and train in research. Very few discoveries are happening in the world so let’s not harp on it. Instead, let’s not focus on it alone but focus on providing BIG grants to younger scientists to train them rather than fund huge grants to established PI’s. INSPIRE fellowships can be given to clinicians and young minds.
Selected suggestions from Q/A
1. Pallavi – Industry internship is needed for young students
2. Balganesh/Anand – smaller companies can partner with CRO’s to provide fully integrated programs
3. Abhishek- what is industry ready mean for a PhD ?- Srikar suggested problem solvingskills as a key and look for jobs that are aligned with your interests and training. Anand suggested that be open to change and newer skill learning
4. Meenakshi – training in coding, etc. is critical even for biologists but not available as a course right now
5. Manish – New educational policy to be rolled out soon where interdisciplinary skills can be included into one degree
6. Jagan – should we focus on affordable medicines or high-risk innovation – Nishith favors going to breakthrough innovation/ precision medicines and be game changers despite the challenges. Commercially new drugs are far more profitable than generics which can fuel innovation. Anand says a judicious mix of both to solve our own Indian problems
7. Balganesh– Industry wants people who can think laterally and practice how you approach a problem
8. Dr. Reddanna – there is a skill gap between academia and industry needs and FABA academy was designed to fill this void thru training courses
9. Jagat -Corporate in India should have training internships like in the USA
10. Ajith – Many CROs are doing their own drug discovery in India now
11. Ajith – How to go from basic science to product innovation for young scientists? It’s mainly your interest and passion for the field of R&D, if you have a good idea or data just present it at the interview.
Major Take home messages:
1. It is important that we don’t deny the existence of an innovation ecosystem in the country. It will take time to mature to bear fruits all year long. The ecosystem is evolving and several sporadic examples of bio-innovations can be seen – Covaxin, various covid and AMR diagnostic kits, Hanugen, Aten Porus, Rotavac, many clinical leads developed from India’s BMS labs, various clinical leads developed from India’s pharmas/CROs – Daiichi Sanyo, Zydus, Rhizen, Syngene, Jubilant, to name a few.
2. Clinicians/Hospitals need to be involved in innovation process along with the basic scientists to work on disease biology
3. Both industry and academia have to work together to promote this ecosystem thru collaborations to create knowledge and skill highways
4. Regulatory and clinical development skills/pathways are not well established in India hampering novel product development
5. Training of young scientists for innovation has to be more well-rounded and include interdisciplinary education, internships at Industry and working at start-ups
The readers can also view the panel discussion on You tube, using the following link: