Veeda, through its V-Konnect series, interacted with Mr. Jayanta Mandal and discussed “Current Outlook for Contract Research Drug Development Segment.”
About the V- Konnect
V-Konnect interview series is a program to get in touch with specialized industry experts to know their views on current relevant subject matters.
About Mr. Jayanta Mandal
Mr. Jayanta Kumar Mandal, M.Pharm, has 20 years’ experience in Pharma R&D, IPR & business development. Worked in the top 10 companies in India.
Lastly, headed R&D, Patent cell, and Pharmacokinetic cells, and managed product selection, all BE and CT studies for the company for all regulated and semi-regulated markets.
Also actively involved in business development for dossier and toll manufacturing business.
Mr. Mandal has a wide range of experience in developing Immediate Release, Sustained Release, MUPS Oral formulations, Liquid and Lyophilized oncology and general Injectable products, Topical Dosage forms, Ophthalmic Dosage forms, and Liquid Oral Products through NDA, ANDA, DCP, Pellets, MRP, and national procedures.
Mr. Mandal has experience in dealing with US and EU patent attorneys and counsels for patent opinion, document discovery, deposition, etc.
Below are the interview questions:
1. What do you think are the most important reasons for pharmaceutical companies to outsource drug development to CRO’s?
A: All big pharma companies cannot cover all products through their in-house R&D.
There are also failures during drug development, and priority for the company to select the important projects relevant for their intended market.
The companies having in-house development with huge infrastructure in place also demand the use of CRO’s for their efficient and cost-effective delivery.
Upgradation of old MAs, life cycle management, filling in the gap of pipeline for the business of pharma companies, and also looking for a quick solution for CRO’s.
Virtual companies do not have a facility or in-house capability to develop projects, and hence CRO’s fill the gap for all these companies.
2. How do you see Contract Research Industry Growth year on year and CAGR in the next five years?
A: There is pressure working in all segments of the pharmaceutical industry, and CRO’s are not immune to that.
The price and ever-demanding regulatory pressure are increasing the cost of development, and the tough phase is expected to be over sooner.
Industry consolidation through mergers and acquisitions is also creating pressure on CRO’s.
It is difficult to predict the year-over-year (YOY) CAGR growth in terms of percentage, but we expect it to be lower than 15% for the next 2-3 years.
Only the best will grow at more than 20%.
3. Which therapeutic segments do you see have business potential across Indian CRO’s?
A: CRO’s are neutral to therapeutic areas and work on a demand basis.
Only the regulatory limitation, even in R&D for Beta-lactam, cephalosporin, etc., limits the CRO to work in this space if they do not have a separate R&D space for these classes.
However, we see a surge in potential or interest in oncology segments and Injectable dosage form development, as the oral segment is crowded.
4. What strategies should Indian CRO’s adopt to nullify competition from International CRO’s?
A: Speed to develop and to retain the cost advantage will keep Indian CRO’s ahead of others.
We have an advantage in language and requisite skills for pharmaceutical development.
Be it chemistry, clinical, or pharmacetics.
The skill set is prevalent in most parts of India.
The regulatory steps or clearances required for R&D are longer in some parts of the country, which need to be made faster and more efficient.
Another factor which will make Indian CRO’s more competitive is to have an in-house scaling-up facility to local government standards to reduce the timeline for pilot BE studies.
The investment needed to do that is high for most of the CRO, and hence an alternate regulatory framework is required to address this to retain our CRO’s competitiveness.
5. How do you visualize Contract Development of Biosimilars with CRO’s and what are the challenges associated with the same?
A: Research and Development on biosimilars is a cost-intensive process that requires a high initial investment with long-term ROI.
It also requires good knowledge of Biology, besides chemistry and pharmaceutical technology.
More close collaboration with universities for biology/biotech competency needs to be developed as a robust, streamlined process to have Biosimilar research to progress.
We lack this at the present moment, which needs to be addressed.
The area of contract research is the future of CRO, as more and more biologics are coming into the market and more are in the pipeline.
In the next 20 years, more and more gene therapy and targeted therapy will be the norm, and there is a good future for Research companies that have embarked on the Biologics space to get a first mover advantage.
6. Do you feel the Need of more contract research organization in India and why?
A: There are thousands of pharmaceutical companies, diagnostic companies, and biotech companies operating in India and for the Indian market, besides serving regulated, semi-regulated, and ROW markets.
The world is moving more towards harmonization of regulatory requirements for drug, diagnostics, and biologics approval processes, with a few local variations.
Current CRO’s have developed over the last 3 decades mostly to cater to the needs of the regulated market.
The space of CRO’s for regulated markets is likely to shrink due to the proliferation of CRO’s in the last 10 years and the consolidation of end-user companies.
The good news for CRO’s is the implementation and upgradation of cGMP norms in the domestic market, where the approval process will require bioequivalence study submission and more vigilant regulatory agencies through their upgraded infrastructure, manpower to implement the cGMP in the industry.
I feel the Indian market will give more growth in the medium term for CRO’s.
7. Looking at the failures of Clinical Trials and BE studies, what is your view on the scientific expertise and knowledge of a contract research organization that can provide support to the Pharmaceutical companies in these areas?
A: For any pharmaceutical product, be it NDA or ANDA, expertise in both pharmaceutical technology and clinical/pharmacology (kinetics/dynamics) is important.
Both go hand in hand as the expertise of drug product to absorb comes from pharmaceutics, whereas how it is absorbed, distributed, and eliminated, eliciting response, is in the domain of clinical /medical experts.
As the biological variations in drug disposition due to the inherent nature of patients/persons and drugs cannot be predicted accurately or controlled, the combined expertise of CRO’s and pharmaceutics will make a long way to resolve the challenges associated with drug development failure of clinical trials and BE studies.
8. How do you see the growth of early-phase and late-phase clinical development by CRO’s in the upcoming years?
A: I do not see a high growth in early phase or late phase clinical development by CRO’s for classical chemical-based drugs due to the transitional change in therapy towards biologics and future targeted gene-based therapies.
Most of the classical early or late phase development of drugs will be shifted more towards mid-size and Venture capital-funded companies.
Biological clinical development programs will drive growth in this segment over the next two decades.
On a closing note, Mr. Mandal added that “As our industry is linked with human beings very closely for its physical and mental health, the industry will always be regarded with respect.
The pace and technology of growth will need to be matched with other industries dealing with health to be relevant.
Artificial intelligence is likely to change the way the healthcare industry currently works in all aspects.
AI will change the way diagnostics are used, prescriptions are made, and dispensing is done.
So is the drug research and development.
I believe that AI will change the way we use animals or human beings in drug development, and will likely be shifted more towards AI-based technologies”.
Disclaimer:
The opinions expressed in this publication are those of the Interviewee and are not intended to malign any ethic group, club, organization, company, individual, or anything. Examples of analysis performed within this publication are only examples.
They should not be utilized in real-world analytic products as they are based only on the personal views of the Interviewee. They do not purport to reflect the opinions or views of the VEEDA CRO or its management. Veeda CRO does not guarantee the accuracy or reliability of the information provided herein
