New Solutions to Support a Pharmaceutical Value Chain that is in Flux | Len Mistretta

Time to market continues to be crucial. Developing processes that can be up and running quickly, enable fast changeovers, and reformulation as needed, can make the difference between success and failure in this fast-paced market.

Contract manufacturing can provide an effective approach to get production running quickly. The pharmaceutical industry has witnessed a shift from a vertically integrated business model to a network of suppliers. Contract manufacturing has evolved as one of the integral components of the pharmaceutical supply chain. The current marketplace has numerous established and emerging companies that can manufacture new products, offering a diverse collection of services. The scale of operation varies from manufacturing for clinical trials to full production. Contract manufacturing includes active pharmaceutical ingredient and finished dosage forms manufacturing. Contract manufacturing can also encompass packaging.

Another trend is the emergence of single-use disposable manufacturing. It is easy to imagine single use for filters or tubing systems but, today, even buffer containers and bioreactors are single use. Entire disposable facilities are also possible today at a fraction of the cost of traditional stainless steel manufacturing facilities. Manufacturing production that has to be up and running quickly, such as for a vaccine for a pandemic, often uses disposables.

China, India and other countries are rapidly developing domestic pharmaceutical, bio pharmaceutical, and generic drug industries. Due to increasing cost pressure and increased local demand, global pharmaceutical companies are locating production to emerging markets. Read More.....

Centre Directs Pharmaceutical Companies to Self Govern on Quality | Len Mistretta

All pharmaceutical companies will have to submit a self assessment and quality rating based on global standards. It is aimed at creating more transparency and increasing the responsibility of the pharmaceutical companies. The Central government has made it mandatory for all pharmaceutical companies to submit a self assessment and quality rating based on global standards in a bid to curb the sale of spurious and substandard drugs.

DRUGS AND COSMETICS ACT REVAMPED

In a major revamp of Drugs and Cosmetics Act, 1940, the Central Drugs Standard Control Organization (CDSCO) under Union Health Ministry has prepared a detailed checklist for all manufacturing facilities. They will now have to comply with the requirements of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) as specified under Drugs and Cosmetics Rules. The checklist prepared by CDSCO also includes World Health Organisation (WHO) GMP and Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) standards. "The tool has been devised with a view to ensure that each pharmaceutical manufacturing unit also carries out self-assessment," said Dr G N Singh, Drugs Controller General (India).

AIMS AT TRANSPARENCY AND INCREASED RESPONSIBILITY OF PHARMA COMPANIES 

We aim to end license raj in the country. We want to device a transparent system in which there are stricter rules and punishment. Pharmaceutical companies would be more responsible with this system and there will be an improvement in the quality of drugs," said Dr Singh.
According to government's own surveys, there are a considerable number of substandard drugs thriving in the country. Based on the samples taken by CDSCO during 2011-12 to 2014-15 (up to September, 2014), 3.33 per cent samples were found to be not of standard quality.  Read More....

Len Mistretta | A Guide to Digital Experience Management for Healthcare and Pharmaceutical Companies

Digital experience management (DXM) refers to the marshaling of strategy, process, and technology to provide highly satisfying digital interactions to customers. DXM is relevant across industries, but it has a special place in the healthcare industry--so much so that I'd like to think of it as the digital equivalent of the mandate to "wash your hands." In other industries serving to enhance customer interactions, DXM is the icing on the cake. But in the healthcare realm, DXM can play an even more crucial role in helping achieve better health outcomes for customers. This article focuses on DXM for organizations in the healthcare industry-hospital systems and other healthcare providers, pharmaceutical companies, and medical device makers.

The healthcare industry is heavily regulated globally and is not an early adopter of digital technologies and techniques, including DXM. But consumers, exposed to superior digital experiences in other industries (such as retail and financial services), have increasingly high expectations of healthcare companies.

As more of the healthcare value chain gets digitized, the importance of DXM is only going to increase. Similar to other industries, a good web presence and useful mobile apps are table stakes for the healthcare industry. Beyond that, here are specific healthcare DXM considerations to help you rise above the fray. READ MORE.....

Medivation shares pop after report that at least five companies interested in deal | Len Mistretta

  Shares of Medivation briefly popped more than 4 percent Wednesday after a report that at least five pharmaceutical companies expressed interest in buying the bio pharmaceutical company.

The stock later pared its gains and ended the day up about 2 percent.
Merck is one of five pharmaceutical companies who have expressed interest in buying Medivation, according to Reuters, citing sources who asked not be identified because the sale process details are confidential.
The other companies listed are: Sanofi, Pfizer, Celgene and Gilead Sciences.

For the past several months, reports have surfaced of drug makers approaching Medivation to express interest in an acquisition.   Read More....

Glenmark Pharmaceuticals' Q1 net profit up 24% at Rs 227 cr | Len Mistretta

New Delhi, Aug 12 () Glenmark Pharmaceuticals today reported a 23.96 per cent rise in consolidated net profit to Rs 226.78 crore for the first quarter ended June 30, 2016, mainly on account of robust sales.
The company had reported a net profit after tax, minority interest and share of profit of associates of Rs 182.94 crore for the corresponding period of the previous fiscal, Glenmark Pharmaceuticals said in a BSE filing.
Consolidated total income from operations of the company also rose to Rs 1,943.05 crore as against Rs 1,647.74 crore for the year-ago period.
Glenmark Pharmaceuticals Chairman and MD Glenn Saldanha said: "In the first quarter of this financial year, nearly all our businesses have rebounded strongly and we have seen good growth across all operating regions except Latam."
The US business continues to perform well and the recent approvals for the business will ensure that the growth momentum continues, he added.

About other markets, Saldanha said: "The Europe business performed well due to strong growth witnessed by the UK subsidiary. The ROW region also rebounded strongly due to a solid performance by the Russian business." Read more.......