3D Printing: An Emerging Game Changer in Pharma Business

On August 3, 2015, Aprecia Pharmaceuticals in the United States took a game changing step towards a new paradigm of the global pharma business. The Company  announced that for the first time ever, the U.S. Food and Drug Administration (US FDA) approved a ‘Three-Dimensional (3D)’ – printed prescription drug for the oral use of epilepsy patients. Although, 3DP has already been used to manufacture medical devices and prosthetics, in the pharma world, this disruptive innovation was never practiced on the ground, till that magic moment came.

The drug is Spritam® (levetiracetam) used as a prescription adjunctive therapy in the treatment of partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures in adults and children with epilepsy.

According to this announcement, Spritam® utilizes Aprecia’s proprietary ZipDose® Technology platform, that uses 3D Printing (3DP) to produce a porous formulation that rapidly disintegrates with a sip of liquid.

The 3DP technology:

3DP technology is broadly defined as a process for making a physical object from a three-dimensional digital model, typically by laying down many successive thin layers of a material.

The originator of this game changing development is the renowned academic institution – ‘The Massachusetts Institute of Technology (MIT)’in the United States. 

Later on, the MIT licensed out the patented 3DP technology for its use in many different other fields. Among pharma companies Aprecia Pharmaceuticals obtained the exclusive rights to 3D-printing technology for pharmaceutical purposes in 2007.

A high potential game changer:

In pharma, 3DP could possibly emerge as a game changing and disruptive innovation, sooner than later. It could radically change the traditional and well-established strategic and operational models of pharma business, especially the drug discovery process, manufacturing strategy and even the disease treatment process, paving a faster pathway for the much awaited ‘Personalized Medicines’, in a large scale. 

Lee Cronin, a Professor of Chemistry, Nanoscience and Chemical Complexity at the Glasgow University, says that the 3DP technology could potentially be used to print medicines of many types – cheaply and wherever it is needed. As Professor Cronin says: “What Apple did for music, I’d like to do for the discovery and distribution of prescription drugs.”

3D Printers would also throw open an opportunity of getting any drug tailor made for the individual patient’s needs, such as, exact dosage requirements, size, shape, color and flavor of the pill and also in the most appropriate delivery systems, just as what Aprecia Pharmaceuticals did with Spritam® by using this technology. 

In this article, I shall highlight the game changing impact of 3DP only in the following three areas of pharma business: 

  • The drug discovery process
  • Drug manufacturing strategy
  • Supply Chain effectiveness
A. Impact on drug discovery process:

A December 29, 2015 article titled, “Click chemistry, 3D-printing, and omics: the future of drug development”, published in ‘Oncotarget, Advance Publications 2015’ deliberates on the potential of 3DP in the drug discovery process.

The paper states, Genomics has unambiguously revealed that different types of cancers are just not highly complex, they also differ from patient to patient. Thus, conventional treatment approaches for such diseases fit poorly with genomic reality. It is also very likely that similar type of complexity will eventually be identified in many other life-threatening ailments.

Currently, a large number of patients are taking medications that may not help them, on the contrary could harm some of them. The top ten best-selling drugs in the United States are only effective in between 4 percent and 25 percent of the individuals for whom they are prescribed, the paper observes.

However, developing new drugs and tailoring such therapy to each patient’s complicated problem has still remained a major challenge.

One possible solution to this challenge could be to match patients to existing compounds with the help of an equally complicated modelling technique. Nonetheless, optimization of a complex therapy will eventually require designing compounds for patients using computer modeling and just-in-time production. 3DP shows a very high potential to effectively address this complex issue.

This is primarily because, 3DP is potentially transformative by virtue of its ability to rapidly generate almost limitless numbers of objects that previously required manufacturing facilities. 

It is also now becoming clearer that with 3DP, scientists will be able to print even the biologic materials, such as, tissues, and eventually organs. Thus, in the near future, it is plausible that high-throughput computing may be deployed to design customized drugs, which will reshape medicine, the article highlights.

In his short ‘Ted Talk Video Clip’ (please click on this link), Professor Lee Cronin explains his working on a 3D printer that, instead of objects, is able to print molecules for a new drug. It could throw open an exciting potential of a long-term application of 3DP for printing, our own customized new medicine by using chemical inks.

In a nutshell,  Professor Lee Cronin elucidates in his ‘Ted Talk’, how could the immense potential of 3D printers be leveraged to catalyze the chemical reactions in order to print real drugs, as and when required, according to the requirements of individual patients.

B. Impact on drug manufacturing strategy:

Not just in drug discovery, 3DP would equally be a game changer in pharma manufacturing, the way it is operated today, including the state of the art production facilities.

This could very much happen in tandem with the 3DP drug discovery research, moving towards personalized medicine, and simultaneously making the same 3DP an integral part of the new drug production line.

Moreover, besides the opportunity of getting any drug tailor made for individual patient needs, such as, exact dosage requirements, size, shape, color and flavor of the tablet and also the delivery system, 3DP technology can be most productively used to manufacture high priced low volume and patient-specific orphan drugs for the treatment of critical illnesses.

Even for Active Pharmaceutical Ingredients (API), the power and potential of 3DP technology can be well leveraged. On March 12, 2015 the ‘Howard Hughes Medical Institute (HHMI)’ of the United States announced that HHMI scientists have designed a revolutionary “3D printer” for small molecules that could open the power of customized chemistry to many. 

It further stated, small molecules hold tremendous potential in medicine and technology, but they are difficult to synthesize without proper expertise. The automated “3D printer” designed for small molecules is a way to get around this bottleneck. The new technology has the potential to unlock access to customized molecules in a way that will drive science forward, on many levels. Moreover, the potential for cost-savings with 3DP is huge, improving the drug profitability significantly.

C. Impact on 'supply chain' effectiveness: 

Currently, the traditional pharma ‘Supply Chain models’ are primarily based on the following:

  • Efficiency largely with high volume operation
  • Need to drive the cost as low as possible
  • Relatively higher-number of workers
  • The inventory cost
  • The real estate cost, owned directly or indirectly, for the entire ‘Supply Chain’ cycle

3DP technology would enable manufacturers shifting the ‘just in time production and distribution’ processes very close to consumers. Such well spread out and ‘just in time’ drug manufacturing activities catering to varying requirements, from very small to very high, would help reduce the cost of logistics, substantially.

This disruptive innovation will enable even the hospitals to print the required drugs at their own locations with, authorized 3DP file downloads, eliminating the need to keep huge inventory and also protecting patients from counterfeit medicines in the ‘Supply Chain’.

Thus, the bottom-line is, the drug companies will be able to print drugs with 3DP technology on real time demand at a large number of selected locations. This will significantly bring down the finished product inventory, starting from companies’ warehouses and distributors to retail and hospital shelves, to almost zero, making pharma supply chain significantly lean and highly effective.

Additionally, it will enable the pharma companies to manufacture drugs also in all developing countries, resulting in improved access to medicine, at a much lesser cost.

Conclusion:

I believe, this technology has already reached a critical juncture, where it is no longer a matter of conjecture that 3DP would ‘soon’ become a game changer, especially for the drug discovery process, manufacturing strategy and supply chain effectiveness of the pharma business, across the world, including India. Getting a prime mover advantage is vital. 

However, the question still remains: how soon will this ‘soon’ be? 

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

RHDS: A Simmering Promise in Despondency

Eric Topol, a leading cardiologist who has embraced the study of genomics and the latest advances in technology to treat chronic disease says, “We’ll soon use our smartphones to monitor our vital signs and chronic conditions in future.”

By clicking on this video clippingyou can watch how Dr. Topol in his talk titled “The Wireless Future of Medicine”, highlights several of the most important wireless devices in medicine’s future – all helping to keep more patients out of hospital beds.

In achieving similar objectives, India’s potential is indeed immense. The good news is, though in India Internet penetration has just crossed 16 percent of its total population, in absolute numbers this percentage reportedly works out to nearly 10 times the population of Australia. According to a report released by the Internet and Mobile Association of India (IMAI) and IMRB, there will be around 243 million internet users in India by June 2014, overtaking the US as the world’s second largest internet base after China. This situation must be leveraged to improve access to healthcare in the country significantly.

‘Remote Healthcare Delivery Solutions (RHDS)’

However, for several other reasons the situation is quite challenging in India. Out of its total population of over 1.2 billion, nearly 72.2 percent live in the hinterland and remote rural areas spreading across over 700,000 villages. In all these places, despite huge prevalence of diseases, inadequate healthcare infrastructure and delivery mechanisms offer an ideal backdrop to explore innovative healthcare solutions such as, ‘Remote Healthcare Delivery Solutions (RHDS)’ or ‘Telemedicine’. In that endeavor, smartphones could play a key role in improving access to healthcare for a very large number of population.

The World Health Organization (WHO) has defined ‘Telemedicine’ as:

“The use of information and communications technology (ICT) to deliver healthcare, particularly in settings where access to medical services is insufficient.”

Thus, to effectively improve access to healthcare, especially in rural India, RHDS holds a great promise.

A complex mix:

Healthcare space in India is generally a complex mix of issues related to access, availability, affordability and quality of healthcare, compounded by inadequate public healthcare infrastructure and delivery system on the one hand and expensive private healthcare facilities on the other. The degree of this complexity is rather stark in rural areas.

In a situation like this, RHDS holds a great promise to satisfy healthcare needs of the hinterland and rural India, as this would entail effective medical care, despite understaffed Primary Healthcare Centers (PHCs) and undertrained healthcare staff, with low start-up costs.

Equipped with modern Internet enabled technologies, RHDS would facilitate transmission of patient related information through SMS, email, audio, video, or other image transmissions, like MRI and CT Scans to relevant specialists of different disciplines of medical sciences located in other places. With RHDS, these specialists can monitor even blood pressure or blood glucose levels of patients on computer screens without examining them in person.

Key advantages:

The key advantages of a structured and well committed implementation of RHDS or ‘Telemedicine’ in india are as follows:

  • Elimination of many costs, including travel expenses for specialists and patient transfers – especially in a critical health situation, improving access to quality healthcare.
  • Reduction of feeling of isolation of the rural medical practitioners by upgrading their knowledge through Tele-education or Tele-Continuing Medical Education (CME) programs.

RHDS in India:

In India, RHDS initiative in form of telemedicine commenced more than a decade ago in 1999, when the Indian Space Research Organization (ISRO) deployed a SATCOM-based telemedicine network across the country. ISRO’s telemedicine program has now been reportedly enhanced to multi-point systems with a network of 400 centers across India.

The good news is, besides Department of Information Technology, the Ministry of Health & Family Welfare and many state governments, some well-reputed medical and technical institutes, corporates and academia have also started taking active interest in this area, especially oriented for the rural population of India.

In this context it is worth mentioning that in March 2014, Biocon Foundation reportedly partnered with Canara Bank and the Odisha Government for an e-healthcare program that aims at setting up of diagnostic facilities in PHCs to improve healthcare access to  51,000 villages.

Simultaneously, the Department of Information Technology has put in place the ‘Standards for Telemedicine Systems’ and the Ministry of Health & Family Welfare has constituted the National Telemedicine Task Force to provide further thrust to RHDS in India,.

To cite an example, US based World Health Partners (WHP) have reportedly set up an extensive Tele-Medicine network in the state of Uttar Pradesh (UP), which has received almost 35,000 calls in two years requesting for services. After receiving the calls, the patients requiring intervention were directed to WHP’s franchisee clinics in the respective areas. This model included three areas namely, Meerut, Bijnor and Muzzafarnagar.

Apollo group, Narayana Hruduyalaya, Aravind Eye Hospital and Asia Heart Foundation are also running similar system in India. Unfortunately, none of these or even all put together can extend such facilities to patients across the whole of India, just yet.

The Market:

According to a report of Infinity research the global market for telemedicine is around US$ 9 billion with a CAGR of 20 percent. However, another report quoting KSA Technopak indicates that the Indian market is currently relatively very small with a market size of around US$ 7.5 Million. Considering future growth opportunities, as deliberated here, RHDS market holds a great promise.

Telemedicine or RHDS market is classified based on the type of technology and services used and usually analyzed on the basis of telemedicine applications, such as Tele-consultation, Tele-cardiology or Tele-dermatology etc. However, Tele-consultation reportedly dominates the telemedicine services market.

To give an idea of its market potential, the BRIC (Brazil, Russia, India and China) telemedicine market was reportedly at US$ 200.5 million in 2009 and was expected to expand at a CAGR of 15.8 percent from 2009 to 2014.

The telemedicine technology market segment forms the largest segment of the overall BRIC telemedicine market and is expected to be US$ 307.4 million by end 2014 with a CAGR of 16.6 percent from 2009 to 2014. The services segment in the overall BRIC telemedicine market is expected to reach US$ 111 million in 2014 with a CAGR of 13.8 percent.

The Challenges in India:

Again there are following two critical challenges in this areas:

  • The biggest challenge is undoubtedly the broadband Internet connectivity.
  • Transmitting patients’ medical records through Internet could infringe upon patient privacy giving rise to ethics related issues, besides avoidable litigations.

I reckon, these concerns can be well addressed, if both the private healthcare providers and the Government together resolve and chart a time-bound pathway to improve access to quality healthcare in a cost effective manner to a large majority of Indian population.

Conclusion:

Various public and private RHDS solution providers are gradually getting actively engaged, though incoherent way, to create awareness about telemedicine in the country. This  brings with it a never before hope of ensuring access to quality healthcare to almost the entire population of the country.

A survey conducted in the United States highlighted that 85 percent of patients expressed satisfaction with their telemedicine consultation. Back home in India, a similar study in Odisha reported a satisfaction rate as high as 99 percent post telemedicine consultation.

Having a large base of medical and IT manpower with requisite expertise in RHDS, India holds a great promise to become a major telemedicine hub even for its neighboring countries, transforming the healthcare delivery scenario in all those places significantly.

Bundling all these, together with the increasing use of Internet enabled smartphones as explained by Dr. Eric Topol in his video clipping above, RHDS does offer a simmering promise in an otherwise despondent healthcare scenario of India.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.