The Indian Chapter of Controlled Release Society (CRS IC) organized its 16th International Symposium on Advances in Technology and Business Potential of New Drug Delivery Systems in Mumbai on February 23 and February 24, 2018. The CRS IC is one of the 15 global chapters of CRS Inc. USA. The symposium received an overwhelming response with more than 200 delegates from major pharmaceutical companies and research institutions from around the country participating in it.

Dr. Anisha Pargal, president CRS IC welcomed the audience on Day 1 of the symposium; followed by an inaugural address by Ajit Singh, President ACG Worldwide and Chairman of Organizing Committee, CRS IC. The ninth issue of CRS IC newsletter was also released on the occasion. Dr. Sudesh Shetty, Partner Risk Consulting, KPMG, India and Dr. Per Falk, Executive Vice President and Chief Scientific Officer, Ferring Pharmaceuticals, Switzerland were invited as key-note speakers in the inauguration session.  

Shetty focused on the key challenges and opportunities faced by the Indian Pharmaceutical Sector, with a brief overview on cGMP compliance, particularly data integrity, and, Uniform Code of Pharmaceutical Practice (UCPMP). He also threw light on ‘KPMG’s ‘Pharma Outlook 2030’ which dwells into the key trends that will revolutionize the pharmaceutical industry and will be driven by advancement in technology, ground breaking therapies and increased access to data by patients.

Dr. Falk, on the other hand spoke of the global evolution and business opportunities associated with Novel Drug Delivery Systems. He also spoke of other macro trends such as a paradigm shift to larger molecules and new modalities, i.e. cell based and gene therapy, necessitating rise of technology in the pharmaceutical sector together with personalized care and digital applications.

The other speakers featured on Day 1 included Dr. Vinod Labhasetwar, Lerner Research Institute, USA; Prof. Kannan Rangaramanujan, Centre of Nanomedicine, Wilmer Eye Institute, John Hopkins School of Medicine, USA and Dr. Matthias Wacker, Goethe University, Institute of Pharmaceutical Technology, Germany. Dr. Labhasetwar emphasized with numerous examples how ‘Simple is Better in Nanomedicine’ wherein he stated how a seemingly simple nanoformulation developed with a strong rationale can be efficiently used to treat a host of complex conditions. The presentation also defined the challenges in moving complex nanoparticles through regulatory pathways and the scale-up process toward eventual commercialization.

Prof. Kannan presented the rationale and developments of systemically delivered hydroxyl-terminal poly(amidoamine) dendrimers directed to neuroinflammation which plays a key role in cerebral palsy, autism and various other CNS disorders. Selective localization of these dendrimers has been validated in pre clinical models and mechanism of the same has been elucidated with applications in wide range of age spectrum ranging from pediatric brain injury to age-related macular degeneration. Dr. Wacker discussed the technologies available to investigate the in vitro release of drugs from next-generation nanotherapeutics. An outline of the current methodologies and applications in formulation development and quality control was presented.

Day 2 of the symposium featured lectures by Prof. Hamid Ghandehari, Departments of Pharmaceutics & Pharmaceutical Chemistry & Bioengineering, USA; Dr. Yogeshwar Bachhav, Associate Director Pharmaceutical Development, Aicuris Anti-infective Cures, GmbH; Mr. Henning Falck, Neuhaus Neotec, Germany; while Dr. Wacker presented his second lecture of the symposium.

Prof. Ghandehari spoke of his research involving development of recombinant polymers for localized drug and gene delivery and as liquid embolics, use of external triggers such as plasmonic photothermal effect and high intensity focused ultrasound to improve delivery of polymer therapeutics to prostate tumors, and investigation of the influence of structural features of silica nanoparticles on their cellular uptake and toxicity.

Dr. Wacker spoke of the unexpected risks and side effects associated with a rising use of nanoscale formulations, posing a threat to human health and the environment. Regulatory authorities all over the world are constantly striving to find a balance between consumer safety and the interests of the industry. Recent progress in the regulatory framework and safety considerations relevant to product development were presented. Dr. Bacchav’s lecture involved formulation of complex NCEs. His lecture covered case studies on use of enabled technologies such as solid dispersions, mesoporous silica particles, nanosuspensions, cosolvent based formulations and lipid based formulations for development of poorly water soluble NCEs. His talk also covered case studies to develop an IV and topical formulation of the poorly soluble and unstable anti-infective compounds under development respectively.

In the concluding lecture of the symposia, Falck explained the different aspects of batch and continuous fluid bed processing options. The lecture emphasized how the choice of the correct processing mode depends on the individual situation and set targets. Most of the challenges of the pharmaceutical production which are very well addressed with batch type equipment can also be matched with continuous plants but there are differences which are worth knowing.