Pharma Focus Asia


Subhadra Dravida, Founder and CEO of Tran-Scell Biologics & TranSTox BioApplications, India.

Product design and delivery is the ultimate interest of biotech industry with recent years witnessing the market opportunity for first-in-class, all new products grow rapidly. The meaning of product can be redefined with set delivery characteristics providing opportunity to the innovators to think smart and different at various stages of development. For instance, in drug discovery and development process, there can be more than 20 different points where each of these spots can be productised with commercial value. In 2016, the total global drug discovery market was valued around US$35.2 billion and it is estimated that the market will grow to some US$71 billion by 2025 indicating the chances on designing and delivering the market needs.

By definition, biology is the natural science while biotechnology utilises biological systems, and living organisms to develop different products. A product could be an article or substance or technology that is manufactured or refined or developed for sale for sure. The list of biotechnological products broadly includes medicines, medical devices, diagnostics, healthcare apps, biofuels, biochips, biomaterials, equipment. An orthodox product in life sciences / biotechnology is a good or offering, the development of which requires the use of unique technical knowhow or techniques that are not obvious to common man and generated from Research & Development (R&D). Any product is expected to have commercial value while the application should be well defined.

All the sectors in the life sciences / biotechnology are assembled around a core set of activities that are allied to the process of either discovering, developing or commercialising covering product life cycle including:

Pre-discovery stage includes an idea, plan, hypothesis, and framework. The end result of this stage could be a design patent, intellectual property that is worth finding a buyer or collaborator involving trade, agreements, commercials etc. It could start as provisional patent and progress with productisation plan. Due to advancements in science and technology, pre-discovery phase is now more founding and sophisticated than ever with highest thrust on technical knowledge, rationale, requirement, and market opportunity with entire globe as the battle field to prepare for. Sometimes, unmet needs could be the starting point while delivery is localised. If in pre-discovery phase of pharmaceutical research, in-depth literature to assist in formulating a new hypothesis or to improvise on the existing solution available is quintessential. Innovators must be able to ascertain connections to their idea from various pieces of literature to throw light on the significance of prior art. Also, typically, prior art does not need to be present physically or be commercially available while settling to the description available somewhere or shown or made something that contains a use of technology that is very similar to one’s new idea.

The discovery stage may include basic or translational research. The end result could be product, such a ‘druggable or undruggable’ target(s) inside the body that affect that mechanism of action, a class of molecule(s) that might be able to affect that target, a new class of molecule with known function, known class of molecule with new function, novel equipment to perform a special function, device to function, device in new integration, or biomaterial composition prototype. This stage is the logical and follow up on determined pre-discovery phase. The design of the ultimate product becomes more structured in this stage to strengthen commercials envisioned with broad emphasis on features of the product. The biopharmaceuticals industry has undergone series of revolutions in the past while discovery stage has been the most innovative space with scope on developing new features, improvising on old ones, deeper characterisations linking to the functions being hunted at small scale. Strong academic liaisons, partnerships in this stage add value to the offerings that are being productised. In India, the discovery phase is either completely non-existent or is weak when it comes to Biopharmaceutical sector contrary to the western scenario. The strongest of the alma maters have been successful in commercialising at the discovery stage of the product life cycle with heavy recognition of the innovative minds and applications in life sciences.

Pre-clinical stage is stereotypically looked at as the start of commercialisation, when a product prototype crosses discovery phase. A product in pre-clinical phase is ready to be trialed with humans, but needs to be established on lower species models. This is an age old ethical practice imposed with good intent on products’ intended applications. Design and impact of pre-clinical studies is strongly felt through the product development and commercialisation process. Classically, pre-clinical studies support biotech entities to accurately and efficiently evaluate prototypes to an optimal and final product model. During this pre-clinical stage, product performance as proposed to comply with regulatory authority standards such as safety and efficacy is demonstrated with an intent to align with global framework. Smart product designs would go through trials of prospective data collection anticipating global commercialisation markets during this phase. Each of these intermittent steps could be productised with deliverable end points designed commanding commercial value during pre-clinical stage in life sciences track. Additionally, cross-functional features like reimbursement plan and marketing collaterals of the products at the late stage application phase could derive support data from pre-clinical validations.

Between product design and delivery comes product packaging covering features, advantages, and benefits. All of these characteristics have to be fixed during pre-clinical stage itself to be demonstrated while conducting in clinics before reaching markets. Product features typically speak on composition, source details, phenotype, quality, function. In the same context, product technical data sheets offer material on the core applications, areas of use, physicochemical, biological properties attributed with a note on personal safety and environment impact. Likewise, product safety data sheets communicate on potential hazards, recommendations for care, handling and use. The additional specifications for product storage is an important data point disclosed in the same product specific data sheet. Details on transport conditions and measures for first aid, accidental spillage, contact control and personal protection are the other key product relevant exhaustive information section in the data sheets. A designated product brochure will capture advantageous traits for the benefit of the user. Advantages of function, characteristics, ease of use are some of the highlighted product collaterals decided in the pre-clinical stage that comes handy in marketing and branding stage.

Product labelling is written information on the product and part of packaging. These labels cover vital information which has to be communicated to the user. Labelling requirements come from the country specific regulatory bodies. USFDA (USA), MHRA(UK), TGA (Australia), CDSCO (India), HEALTH CANADA (CANADA), MCC (South Africa), ANVISA (Brazil), EMEA (European Union), SFDA (China), NAFDAC (Nigeria), MEDSAFE (NewZeeland), MHLW (Japan), MCAZ (Zimbabwe), SWISSMEDIC(Switzerland) , KFDA(Korea), MoH (Sri Lanka) are some pharma-specific regulatory agencies in respective countries typically deciding product-specific labelling requirements. Any new product to be released in the market has to abide by specific labelling guidelines of geography/market specific regulatory bodies. The development of biologic drugs and patient-friendly delivery methods necessitate innovative packaging material. The need for novel, discreet, no pain, easy to apply like delivery platforms that could be productised is forecast to expand as the demand for biologic therapies is anticipated to grow throughout the next decade.

Product quality control documentation and implementation of set methods aims to assure quality at every production stage. This practice essentially avoids product recalls, anticipate any production specific delays and majorly improve quality control budget. All the relevant quality control and assurance templates have to be designed and validated during pre-clinical stage of the product life cycle. There are many methodologies to track product quality control in biopharmaceutical processes. The most basic one is through checklists to check off items that are vital to produce and sell products. Control chart is a dynamic tool that can predict outcomes, analyse variations to correct problems in quality as they happen. Histogram and pareto chart are few other product quality control tools that are products themselves within the process.

Testing or applying the product in humans is the most decisive phase of the product life cycle. This clinical stage typically happens in four distinct phases. There are significant regulatory essentials to pass before entering each new phase: phase I generally tests for the safety of the product by evaluating tolerance, generally in healthy volunteers. Phase II tests for efficacy and side-effects in a predetermined product application specific sample size. Phase III is for safety and efficacy determination of the product in bigger populations. After this phase, if safety and efficacy data is shown to meet standards set, the regulatory agencies will approve the product for sale and general use. Ninety-five per cent of the products at this stage would command the rightful valuation and stand big for acquisitions.

Factors such as globalised market, competitive environment, disruptive technological changes, and shorter product lifecycles have made first-in-class product development in biotechnology an important strategy for companies in general and for dynamic industry in particular. Irrespective of innovative level, any new product development is considered to be a high-risk and expensive process while success factors are industry specific.

In the midst of technology, patents, and products designed to deliver, there is an interesting element of productisation of services to the process. Typically,Contract Research Organisations (CROs) undertake contract of third-party R&D requirement to provide their services. Even for these service providers in life sciences/biotechnology, there is scope to productise their services. The perceived advantages of productising services are to automate, outsource non-core things; and to invest in getting faster and better in delivering. These benefits would in turn trickle down to improving the top line and enabling higher quality delivery. This productised service with improved outcome and deliverables would command more in value chain automatically.

The new drug discovery market has seen rapid progress in the recent past with the potential to reach US$71 billion in 2025 itself, which is not too far to witness. The industry is focusing on first-in-class technologies, products, and approaches to come up with cure for debilitating diseases.

--Issue 33--

Author Bio

Subhadra Dravida

A Scientist by profession, Subhadra Dravida led global stem cell research and commercialization initiatives in regenerative medicine and drug discovery domains for over 12 years. She holds over two dozen patents in the field of regenerative medicine and has significant expertise in converting promising research into business opportunities.

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