While at one end, companies continue to push boundaries of frontier medicine through break-through innovations, the regulatory landscape also continues to evolve to provide a more conducive commercialization landscape. On these lines, the NIH and FDA have combined their forces to together streamline and simplify research and approval process. This is an encouraging effort in the direction of modernizing oversight of gene therapy and eliminating duplication of reporting requirements that do not exist for any other field of research. So far, for gene transfer clinical trials, sponsors have to register their study with FDA as well as NIH along with submission of annual reports and reporting of serious adverse events to both the bodies. In the new proposed amendment, NIH is seeking to remove protocol submission, review, and reporting requirements and modify the roles and responsibilities of the Recombinant DNA Advisory Committee (RAC).
The field of cell and gene therapy also has a vibrant M&A landscape, as companies scramble to jump on the bandwagon of regenerative therapy, as signified by several past deals. In yet another deal this month, PTC Therapeutics, has entered into an agreement to acquire biotech company AgilisBiotherapeutics, developing gene therapy programsfor patients suffering from rare CNS disorders.
At the other side of the world, China’s National Drug Administration (CNDA) has granted a rapid approval for Roche’s Alectinib. Marketed as Alecensa,it is an oral drug that blocks the activity of anaplastic lymphoma kinase (ALK) and is used to treat non-small-cell lung cancer (NSCLC). This is perceived as a positive sign redeeming China from its notoriety for delayed review process. The regulator has been taking several regulatory revamp efforts ever since its rebranding and restructuring in 2013.
Deal Announcement – Series A fund raise for health tech venture HealthSignz
Sathguru Management Consultants Acted As Sole Transaction Advisor To HealthSignz Technologies On Its Equity Fundraise
Indian Pharma: Enabling the Transition to Innovation Led Growth
Excerpts from the Assocham Sathguru publication released at the Assocham Pharma Conclave, May 2018
Industry at a Crossover – Quest for Higher Value Generation
– Industry in transition, with rapid shifting of gears in novel chemical and biological entities
– Large pharma companies carving their own niche with some degree of success in specialty Pharma with the 505(b) (2) pathway
– Active engagement in biosimilars for domestic markets, with need to step up pursuit to regulated as well as ROW markets
– Novel vaccines –gradual stepping up to innovation led products with some commercial success
– Robust drug discovery capability in CROs, triggered by rich expertise gained from discovery work for MNCs
Triggering Innovation Leapfrogging – Global Benchmarks
– Indian innovation ecosystem primed from several ends – Ease of access created for seed and early risk funding through TDB & BIRAC i3 Program; Incubation Infrastructure fostered and innovation hubs nurtured; Fiscal incentives such as concessional taxation on royalty income
– International benchmarks for innovation-led growth – Hong Kong, South Korea & Israel
Innovation Led Growth –Recommendations for Leapfrogging Momentum
Need of the hour for next leg of growth include
– Scale-Up Funding and Tech Access Mechanisms
– Strengthening institutional backbone, industry-academia collaboration and IP perception
– Globally comparable fiscal incentives