Dr. Shrilakshmi Desiraju a pioneer in Probiotics Space is the Co-founder and CEO of Triphase Pharmaceuticals. After relocating from Canada to India, Dr. Desiraju started her journey of innovation with Triphase in the field of Probiotics in 2009. Triphase has successfully raised funds (up to 1 Crore) from debt financing under CGTMSE scheme, funds from angel investors and also secured series A venture funding by a fortune 500 pharma company to develop robust Research and Development in the field of Probiotics.

Triphase was awarded a US, Canadian and European PATENT for the technology by which Probiotics bacteria could withstand temperatures of up to 240 degrees. This is the first time in the world that a disruptive platform innovation has been successfully completed. In one single stroke the company had eliminated any need for cold storage which meant a huge cost saving in the probiotic industry. A state of art research and development wing for probiotic research at Mysore has been established since 2009.

Dr. Desiraju was the speaker for ‘Innerview – Only the Paranoid Survive’, our weekly live 45-minute motivational and inspirational talk show which features interviews of industry experts who bring forth informative and life experiences and techniques to help shape and gear you up, to succeed. Dr. Desiraju is an MBA in Technology Commercialisation from University of Alberta; PhD in Medicinal Chemistry from Vikram University and a postdoctoral from the Indian Institute of Science. The first big challenge that Triphase solved was in eliminating the cold chain from the Probiotics industry.

As the pandemic spread, India was put under strict lockdown for the first time. Out-patient departments as well as doctors’ clinics suspended their services in order to avoid becoming the virus hotspots. Subsequently, patients with chronic ailments, minor diseases, and those in post-surgery or injury rehab stage were left without any medical support as hospitals catered to critical patients or serious Covid-19 cases.

The coronavirus epidemic not only placed a mammoth strain on the global health care sector’s workforce, but also on infrastructure, and supply chain. On the same side, it also exposed social inequities in health and care. The Covid-19 also accelerated the changes across the pharma industry and forced many public and private health systems to adapt and innovate in a short span.

A number of foundational shifts are happening from and being exacerbated due to the spread of the coronavirus. The consumers are increasing their involvement in health care decision making. Then, there is a rapid adoption of virtual health and other digital innovations. Similarly, there is a push for interoperable data and data analytics use. In the same way, unprecedented public-private collaborations in vaccine and therapeutics development are also taking place in a big way. Amid these changing dynamics, governments, health care providers, payers, and other stakeholders around the globe are being defied to quickly pivot, adapt, and innovate.

The Covid-19 pandemic has been proving a transformational moment for the pharma industry. It has pushed many pharma companies to re-examine themselves at various levels; the way they used to do businesses. Many of those changes are likely to prove difficult to reverse. The race for developing a coronavirus vaccine has stimulated innovation across the industry. However, the sector has been building this thrust for years.

In the past one year, the pandemic has shaken the world to its very core. Several biotechnology companies and pharmaceutical companies have been spending months and millions of dollars on the research and development of the much-awaited vaccine for COVID-19. 

Amongst several players in the COVID vaccine race, two of them have finally received the approval for public consumption in India. The Drug regulation has given the green light to Covaxin, locally-made by pharma company Bharat Biotech and Covishield by Oxford-AstraZeneca produced by Serum Institute of India. 

Though we have two vaccines approved for public consumption, there are more COVID-19 vaccine candidates in different stages of the trial who could potentially be ready for being authorised for use in the near future. With eight COVID-19 vaccine candidates in different stages of the trial, many could be ready for being authorised for use soon. These candidates are still in trial to test the safety and efficacy when injected into human bodies. Front-runners often don’t share their intellectual property however it is safe to say that there are already more than fifty vaccines in clinical trials across the globe. Within our country the following vaccines are in trial stages:

Zydus Cadila – A vaccine developed by Ahmedabad-based Zydus-Cadila, ranked 4th in the Indian Pharmaceutical Industry. In 2014, they launched the world’s first adalimumab biosimilar under the brand name Exemptia. It also launched its first research-based drug molecule Saroglitazar for the treatment of Diabetic Dyslipidemia.

Biological E Ltd – The Hyderabad based pioneer Indian private vaccine-making company has collaborated with US-based Dynavax and Baylor College of Medicine to develop a COVID-19 vaccine. Established during the Swadeshi movement, Biological E focuses on Branded Formulations, Speciality Generic Injectables, Synthetic Biology and Vaccines and Biologics.

Gennova Biopharmaceuticals Ltd – The Pune based biotech has collaborated with Seattle-based HDT Biotech Corporation to use pieces of genetic code to cause an immune response to come with HGCO19, India’s first mRNA vaccine. Gennova has 7 products in the market; 5 biosimilar, 1 generic and 1 pioneer product. Gennova’s Tenectase is a pioneering work, where for the first time ever a 3rd generation thrombolytic was approved for arterial ischemic stroke (AIS).

Bharat BioTech International Limited – The biotechnology company founded in 1996 which developed the authorised Covaxin, is coming up with a new Nasal Vaccine. The Hyderabad based company has previously made 16 successful vaccines and exported them to 123 countries.

Dr Reddy’s Lab – Dr Reddy’s Lab in collaboration with Gamaleya National Centre in Russia is developing the Sputnik V vaccine. The company has over 190 medications, 60 active pharmaceutical ingredients. 

Serum Institute of India – Adar c. Poonawalla’s Serum Institute of India was granted emergency use authorisation to go ahead with Covishield by Oxford/AstraZeneca is collaborating with American vaccine development company Novavax to develop a second COVID-19 vaccine.  Serum Institute of India has already manufactured 5 crore doses of the vaccine and is building a stock with at-risk manufacturing and stockpiling licence from the DCGI. They aim to produce 30 crore doses by July 2021. 

After months of trials and painstaking efforts, the COVID vaccine race has finally come to an end. Amongst several players in the vaccine development including Zydus-Cadila, Hyderabad-based Biological E, Pune-based Genova, The Sputnik V vaccine candidate by Dr Reddy’s Lab and Gamaleya National Centre in Russia and another vaccine by Serum Institute of India and American company Novavax, India’s drug regulation has given the green light to Covaxin, locally-made by pharma company Bharat Biotech and Covishield (Oxford-AstraZeneca vaccine).

On January 1, 2021, the Central Drugs Standard Control Organization (CDSCO) reviewed the application of front-runner vaccine developers and granted emergency use authorization for the Serum Institute of India (SII) to go ahead with Covishield. The vaccination process began on January 6. Covishield was the first vaccine approved for public use while Pfzier and Bharat Biotech vaccines were in review. The CDSCO also looked into India’s Covaxin, co-developed by Bharat Bharat Biotech and Indian Council of Medical Research (ICMR).

Bharat Biotech International Limited, an Indian biotechnology company founded in 1996 that has previously made 16 successful vaccines and exported them to 123 countries. It is headquartered in Hyderabad, India conducts research and development in drugs, vaccines, bio-therapeutics, pharmaceuticals, etc. 

Bharat biotech developed an eco-friendly recombinant and strain derived Rotavirus vaccine named ROTAVAC, India’s first and largest efficacy trial. They were also the pioneers in the development of vaccines for viral diseases like Chikungunya and Zika.  it is also the first company from the developing nations to carry out human trial challenges. Bharat Biotech used a sample of the coronavirus which was isolated by India’s National Institute of Virology.

AstraZeneca plc is a British-Swedish multinational pharmaceutical and biopharmaceutical company founded in 1999. Headquartered in Cambridge, England, it produces products for major diseases including cancer, cardiovascular, gastrointestinal, infection, respiratory and inflammation.

It is amongst the world’s largest pharmaceutical companies, and has acquired several acquisitions over the past decade. In 2002, its drug Iressa was approved in Japan as monotherapy for non-small cell lung cancer. In 2014 the company received approval for Olaparib in the treatment of women with advanced ovarian cancer with a BRCA genetic mutation. In 2017, it was the eleventh largest drug company in the world based on sales and ranked seventh based on Research and Development investment. With the onset of the pandemic, they donated PPE, including 9 million face masks, to help international health organizations mitigating the COVID-19.

The Oxford-AstraZeneca COVID-19 vaccine is a medically tested safe vaccine that has no major side effects as reported during human trials. It has shown 62% efficacy when trial participants were given two full doses. 

Adar Poonawalla, Chief Executive Officer, Serum Institute of India reports that they have already manufactured 5 crore doses of the vaccine and are building a stock with at-risk manufacturing and stockpiling license from the DCGI. They aim to produce 30 crore doses by July 2021. 

AstraZeneca also had a licensing agreement with Serum to supply one billion doses for low-and-middle-income countries, with a commitment to provide 400 million before the end of 2020. Some of the first doses were shipped to Bhutan, Maldives, Bangladesh, Nepal, Myanmar and Seychelles. Till now, only Covishield has been exported as gifts or commercial agreements.

In its initial phase of the drive, India plans to vaccinate almost 30 crore people including one crore healthcare workers, 2 crore frontline and essential workers and 27 crores elderly above 50 years with health issues, etc. With eight COVID-19 vaccine candidates in different stages of the trial, many could be ready for being authorized for use soon.