Development and Execution of In Vivo Bioassays
January 8, 2022
Veeda through its V-Konnect series interacted with Mr. Jayanta Mandal and discussed about “Current Outlook for contract research drug development Segment”
V-Konnect interview series, is a program to get in touch with specialized industry experts to know their views on opinions on current relevant subject matters.
Mr. Jayanta Kumar Mandal, M.Pharm has 20 years’ experience in Pharma R&D, IPR & business development. Worked in 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 bus
Mr. Mandal has 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 s 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.
1. What do you think are the most important reason of the pharmaceutical companies for outsourcing the drug development to the CRO’s?
A: All big pharma companies cannot cover all products through them 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 demands the use of CRO’s for their efficient and cost effective delivery. Up gradation of old MA’s, life cycle management, fill in the gap of pipe line for the business of pharma companies also looks for a quick solution toward the CRO’s. Virtual companies do not have 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 next five years?
A: There are pressure working in all segments of pharmaceutical industry and CRO’s are not immune to that. The price and ever demanding regulatory pressure is increasing the cost of development the tough phase is expected to be over sooner. Industry consolidation through merger and acquisition also creating pressure on CRO’s. It is difficult to predict YOY CAGR growth in terms of % but we expect it to be lower than 15 % for 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 area and work on demand basis. Only the regulatory limitation even in R&D for Betalactam, cephalosporin etc. limits the CRO to work in these space if they do not have 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 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 on language and requisite skill for pharmaceutical development. Be it chemistry, clinical or Pharmaceutics. The skill set is there prevalent in most part of India. The regulatory steps or clearances required for R&D is longer in some part of the country which needs to be made faster and more efficient. Another factor which will make Indian CRO’s more competitive is to have in house scaling up facility of local govt. standards to reduce time line for pilot BE studies. The investment needed to do that is high for most of the CRO’s and hence 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 Biosimilar is a cost intensive process which requires 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 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 in pipe line. In next 20 years, more and more gene therapy and targeted therapy will be the norm and there is good future for Research companies who embarked on the Biologics space to get 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 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 process with few local variations. Current CRO’s have developed over last 3 decades mostly to cater to the need of regulated market. The space of CRO’s for regulated markets are likely to shrink due to proliferations of CRO’s in last 10 years and consolidation of end user companies.
The good news for CRO’s is implementation and up gradation of cGMP norms in domestic market where the approval process will require bioequivalence study submission and more vigilant regulatory agencies through their upgraded infrastructure, man power to implement the cGMP in the industry.
I feel the Indian market will give more growth in 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 contract research organization that can provide support to the Pharmaceutical companies in this 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 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 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 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 the growth in this segment for next 2 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 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 will likely be shifted more towards AI based technologies”.
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 anyone 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 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