Pharma Bio World - January 2015

January 2015 l

Vol.13

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Issue 6

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Mumbai

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Price ` 150

PHARMA BIO WORLD

www.pharmabioworld.com

JANUARY 2015 VOL. 13 ISSUE 6 MUMBAI ` 150

28-31 January 2015, Mumbai, India 28-31 January 2015, Mumbai, India

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4  January 2015

Pharma Bio World

FEATURES 8

Risk Mitigation in Pharma Logistics – Dr Madhusudan P Dabhole

20

Supply Chain Challenges to Pharmaceutical Industry – Akhil Chandra

24

Leveraging Mobility for the Life Sciences Industry – Govind Srinivasan

8 27

Air Cargo in Indian Pharmaceutical Industry – Willy Ko

29

Disparity in FTE Rates - A Significant Driver for Discovery Research Services in the Emerging Markets – C Vivek

MARKET RESEARCH 20

32

Type 2 Diabetes Therapeutics: A Highly Competitive and Growing Market – GBI Research

34

Drug Launch and Phase 3 Trial Watch List for Top Therapeutic Areas – Frost & Sullivan

NEWS UPDATE 27

39

Press Release

40

Pharma News

43

Biotech News

CORPORATE AFFAIRS 46 50

Product Trends Events Diary

BACKYARD 32

51 52

Book Shelf Ad Index Next Issue Focus: Vaccines

6  January 2015

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Risk Mitigation in Pharma Logistics Pharmaceutical supply chains are fraught with complexities. Increasing supply chain complexities will pose risks to pharmaceutical safety, ultimately impacting businesses and, most importantly, patients.

This article explores the trends and risks currently impacting the pharmaceutical supply chain, as well as the strategies to curb the risks.

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ogistics is regarded as a crucial part of the pharmaceutical industry since the activities are highly time sensitive. In addition, pharma products need temperature-controlled storage and distribution to maintain the quality. The pharma logistic chain is quite intricate and highly responsible to ensure that the right drug, reaches the right people at the right time and in the right condition to fight against disease and sufferings.

digital marketing techniques on account of expiration of patents and time constraints involved in drug approvals.

4) Pharmaceutical companies have been increasingly focusing on integrating and aligning key supply chain parameters, such as capacity, inventory levels, and lead times, with market demand. 1

Trends in Pharma Logistics

The product should be transported in such a way as to ensure that the label claim for temperature is maintained throughout shipping, and the Manufacturing Authorization Holder needs to be able to demonstrate that the product was not subject to conditions that may compromise its quality.

One of the most significant shifts of recent times has been the rapid reorganization o f t h e p h a r m a c e u t i c a l i n d u s t r y. T h e requirement of achieving economies of scale and managing the cost of innovation has led to the widening of the industryâ&#x20AC;&#x2122;s horizons. This has been coupled with globalization as a key undercurrent driving both distribution and outsourcing models across all regions. Indeed, the global pharmaceutical engine has shifted to developing economies, with countries such as China, India, Brazil, Turkey, Mexico, South Korea and Russia becoming fast growing markets globally thereby shifting the balance from traditional drug markets such as the US and Western European countries. 1

Dr Madhusudan P Dabhole Group Manager â&#x20AC;&#x201C; Bioprocess Richcore Life Sciences Ltd 8 ď&#x201A;&#x192;January 2015

Omer Abdullah, Managing Director, The Smart Cube, and Inc identifies four trends that will directly influence pharmaceutical supply chains in 2013-2014: 1) Pharmaceutical companies have been increasingly focusing on aligning research and development capabilities to cater to the escalating demand for drugs globally.

2) With the rapidly volatile economic environment globally, pharmaceutical companies have increasingly started focusing on amplifying their go-to market capabilities as well.

3) Pharmaceutical players have downsized their sales forces and started adopting

Increasing Complexities in Pharma Logistics

It is not enough to know where the materials and products are shipped from and where shipped to; the MAH and Qualified Person need to understand the routes by which they are being supplied and the transport conditions. A risk based approach should be utilized in assessing the suitability and controls required on the transport routes used to supply materials and products. The complete address of each party should be documented in the QTA/ contract and on order and delivery documentation to enable accurate and complete checking where appropriate of such addresses on receipt of the goods.

Mapping of the supply chain is applicable to the whole supply chain, and should include API, critical excipients, intermediates and finished product transportation, storage and distribution facilities. The roles and activities of each party in the supply chain should be documented, ideally in the form of a Quality Technical Agreement (QTA)/ contract. It is necessary to ensure that there are suitable contracts between manufacturers, wholesalers, distributors, agents and brokers that will ensure that the product is traceable throughout the Pharma Bio World

supply chain and the product integrity is always maintained. A distinction should be made between the meaning of the supplier, manufacturer, broker and distributor within the QTA/ contract.

Meeting the Specific Logistic Requirements for Biologic Products The companies that succeed in bringing commercially viable biologics and cellbased therapies to the market will be those that considered the cold chain and logistical requirements of their product from the very beginning of product development.

According to Daniel H O’Donnell, Jr, Associate Director of Cell Therapy Logistics at Fisher BioServices in Rockville, Maryland, the successful cell therapy companies will be those that adopt packaging that is friendly to standard liquid nitrogen racking systems, who understand qualification and validation processes, and who consider the capabilities of clinical sites.

Companies with biopharmaceutical products in development frequently fail to address cold chain distribution until the product is nearing clinical trials. This is acceptable for small molecule drugs; however, the complexity of maintaining cold chain, combined with ever more stringent regulatory requirements, creates a minefield of challenges in moving a therapy from the manufacturer’s door to the patient bedside.

Companies that wait until their product is ready to enter clinical trials before considering packaging and cold chain distribution may inadvertently limit their product’s commercial viability.

S t r a t e g i e s t o E n s u r e Te m p e r a t u r e Control throughout the Supply Chain Maintaining the strict temperature parameters required to ensure product stability is relatively straightforward in 10 January 2015

the plant or laboratory setting where product remains in a stationary location and equipment is suitably calibrated, and where personnel are trained accordingly.

But, what happens to high-value products or APIs, which must travel thousands of miles over a period of hours or days, secured by nothing but a temperaturecontrolled packaging unit? How can smaller consignments that are further exposed to risk because of low thermal mass be protected from potentially damaging temperature excursions?

Identify High-Value Shipments - To develop an effective cost/performance strategy, it is imperative for pharmaceutical shippers to first clearly define their critical shipping requirements. Not all transports are equally important in terms of their need for temperature stability, speed and/or security. For less strategic shipments, standardized transport solutions may be appropriate. For those all-important h i g h - v a l u e s h i p m e n t s , h o w e v e r, a more customized logistics approach is recommended.

• A c t i v e p h a r m a c e u t i c a l i n g r e d i e n t s (APIs) with strict temperature controls.

• Vaccines.

• Batch samples pending bulk supply approval.

• Batch samples being shipped for quality audit purposes.

• B i o l o g i c a l s a m p l e s d e s t i n e d f o r laboratories.

• P r o d u c t s w i t h s i g n i f i c a n t t i m e l i n e requirements (ie, emergency therapeutic products being used for treatment).

▪ Products with zero temperature excursion tolerance or limited stability data (i.e. investigational drugs).

In reality, identifying shipments with high monetary value is straightforward. A million-dollar drug is a million-dollar drug.

Identifying a shipment with a high intrinsic value, however, may not be quite as simple.

While all pharmaceutical shipments are inherently important, some will be truly mission-critical as evidenced by the consequences of a product failure; • The impact on a patient from a drug shipped for emergency intervention that doesn’t arrive on time or What types of shipments qualify as ‘high within specification. value’? These shipments might include: • High-value (commercial or intrinsic) or • The potential disruption to production schedules if APIs experience irreplaceable products.

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temperature excursions during transit and require quality review and/or replacement.

• Study results delayed or jeopardized by product stability or sample quality questions.

• F a i l e d q u a l i t y a u d i t s o r a p p r o v a l s denied by regulatory agencies.

keep their budgets in check for, unlike larger bulk shipments, there are rarely economies of scale to be found. There are, however, a growing number of reliable, field-tested packaging units on the market that can meet the most demanding transport requirements of high commercial or intrinsic value products irrespective of their size.

management and intervention. These systems offer a wide range of options to pharmaceutical shippers seeking reliable packaging for consignments of virtually any size — from a single sample or vial of medication right up to a pallet or more of product.

Generically speaking, these packaging options pair an outer casing or shell with In each of these cases, the cost to the organization or to the patient may G e n e r a l l y s p e a k i n g , t e m p e r a t u r e an internal cooling medium to maintain the far exceed the monetary value of the requirements for pharmaceutical shipments required temperature range. Depending on vary dramatically, but fall into one of the specific temperature requirements and compound or drug. packaging design, coolants may take the eight ranges: form of dry ice; frozen and/or refrigerated Therefore, prior to shipping, pharmaceutical • +30°C to +37°C ‘gel-packs’ or Phase Change Material professionals should ensure that the • +15°C to +25°C (PCMs) fitted into the interior; insulated ramifications of a temperature excursion • +2°C to +25°C panels that form part of the structure of or product failure are clearly understood • +2°C to +8°C the casing; or liquid nitrogen. Beginning and use this insight to define high-value • -25°C to -15°C with the most basic of these units, we will • -35°C to -20°C shipments accordingly. examine today’s most commonly used • -80°C to -60°C packaging options and identify the most Shippers should ask themselves: if this • Below -150°C appropriate applications for each. shipment does not arrive in the stipulated condition, what will the impact be on the A s w i t h a n y t e m p e r a t u r e - c o n t r o l l e d The resources in question include patient? On the study? On production? commodity, the danger of irregular cooling, t i m e , k n o w l e d g e , e x p e r i e n c e a n d On the quality review department? On warming and/or refreezing brought on by financial considerations. regulatory approval? On product roll-out? external temperature changes, packaging On the company and its reputation? If the m i s u s e / f a i l u r e , o r m i s h a n d l i n g c a n S h i p p i n g h i g h - v a l u e p h a r m a c e u t i c a l answer to any of these questions cannot compromise product quality. Therefore, shipments over long distances and within be shrugged off or does not fall within the second critical decision to be made their prescribed temperature range — acceptable risk parameters, the shipment l i e s i n s e l e c t i n g t h e b e s t p a c k a g i n g consistently and without excursion — is option for each specific shipment while a collaborative effort. For this reason, is high-value. understanding the limitations of each. pharmaceutical shippers are encouraged Understand the Limits of Packaging - to develop open communications with Whether shippers are forwarding a small The Mechanics of Temperature Control a well- qualified and trusted logistics quantity of high-value investigational drugs - While ‘active’ container units rely on provider and work together to develop a halfway around the world or transporting electricity and/or batteries to power the practical logistics plan. delicate APIs on routes that experience fans, thermostats and internal refrigeration dramatic changes in climate over a period components that keep internal temperature Identifying the types and frequencies of of several days, their primary goal is to in t he c orrec t range, an entire array high-value transports, estimated weights ensure product stability from origin to of packaging exists that is structurally and volumes of individual shipments, simpler. Instead, it relies on the correct temperature requirements and projected destination and at all points in between.

When transporting smaller shipments, choice of packaging and cooling mediums destinations — even in theoretical terms this can represent a serious conundrum for specific temperature requirements — will help both shipper and service for pharmaceutical firms attempting to s u p p o r t e d b y k n o w l e d g e a b l e h u m a n provider better understand department or company needs with a view to optimizing overall resources.

“It is necessary to ensure that there are suitable contracts between manufacturers, wholesalers, distributors, agents and brokers that will ensure that the product is traceable throughout the supply chain and the product integrity is always maintained.”

12 January 2015

Consolidating all high-value shipments with a single provider, perhaps even including colleagues in other locations or countries within the plan, may encourage pricing Pharma Bio World

flexibility. The worldwide pharmaceutical c o m m u n i t y i s a clo se -kn it o n e a n d a service provider with global reach may be able offer attractive incentives for broader geographical consolidation.

Te m p e r a t u r e S e n s i t i v e P a c k a g i n g Essentials Expanded Polystyrene (EPS) and Expanded Polyurethane (EPU) insulation systems — consisting of pre-formed outer shells fitted inside with frozen and/or refrigerated coolants — are still in common use and represent an economical choice for shorter-distance and local transports.

When used in conjunction with dry ice, these systems represent the container of choice for frozen shipments requiring a -80°C to -60°C environment.

Semi-active solutions are so named because the cooling/ heating elements inside the packaging may differ from the temperature of the commodity. As such, these systems are unable to regulate their internal temperatures and require different gel-pack conditioning/configurations for winter and summer transits even on the same routes. Because of these internal variances, contents may experience decreased temperature stability, especially during longer transports, during transits that are undertaken in colder climates, in the event the product is stored incorrectly or, in some cases, in a refrigerated setting.

For this reason, semi-active units are best utilized in controlled, short-haul routings.

Most typically used for +2°C to +8°C shipments and available in a variety of sizes up to one euro/US pallet and larger, this packaging alternative is usually used only once. They may be purchased outright by the shipper or supplied by the logistics provider and are disposed of at the final destination, rendering them somewhat of an environmental liability.

These systems are most appropriate for shorter routes, like those that occur between a warehouse or distribution center and a hospital, pharmacy or laboratory, where they represent a low 14 January 2015

dose unit/package cost ratio. Despite their simplicity, these units require configuration by knowledgeable personnel to optimize reliability and product stability based on product temperature requirements and unit size. As such, they may be more prone to simple human error including the inadvertent mix-up of frozen and refrigerated gel-packs, or mistaking winter and summer configurations.

Passive Packaging Solutions Providing proven temperature control over longer distances, passive packaging systems are more technologically advanced, relying on engineering to create a highly stable interior storage environment that mirrors the temperature of the commodity. Independent testing suggests that these systems perform from five to seven times more efficiently than the Expanded Polystyrene/Expanded Polyurethane systems described above due to the superior insulation technology.

A l t h o u g h t h e r e a r e s e v e r a l d i ff e r e n t models currently on the market produced by different manufacturers, key design components of all passive packaging systems include: • A rigid outer casing.

• Vacuum insulated thermal panels.

• A t e m p e r a t u r e c o n t r o l m e d i u m , o r Phase Change Material (PCM).

Typically these components are reusable (although single-use models do exist).

Some models may also feature a removable outer carton and/or an interior bag/product container which is single-use and replaced for each shipment. These systems are available in a variety of sizes — from 1L up to two EU pallets — to suit individual shipping needs and are generally designed to accommodate shipments with the following temperature requirements: • +15°C to +25°C • +2°C to +8°C • -25°C to -15°C Other models, although less common, are also available to accommodate shipments

requiring the outer limits of high and low temperature ranges: • +30°C to +37°C • 35°C to -20°C Outer casings may be made from a variety of materials including moulded plastic or double-sided laminated/ coated plywood depending on the manufacturer, and more sophisticated units may be reinforced with features such as aluminum edges and/ or stainless steel ball corners for greater strength and security during shipping and to prevent direct contact with ground surfaces. Some larger units can be stacked on permanent pallets for forklift access or block loading.

Structurally the walls, floor and lid of the outer casing of a passive unit are fitted with a series of vacuum insulated panels. These panels are made from foam core covered with an impermeable metallic membrane, which is sealed, creating a vacuum layer and a leak-proof compartment within the box. Depending on the unit, a plastic or metal liner may be inserted to protect the vacuum panels from puncture.

Providing the cooling mechanism for these systems are refrigerants known as Phase Change Material (PCMs) or ‘accus’ which are comprised of either paraffin or a saltbased solution. Given the nature of their advanced design, PCMs store energy differently from water-based refrigerant gel- packs, with the key differentiator being that energy stored in the PCM is only released if and when required. This capability allows for greater precision and temperature control when maintaining product stability over long distances, multiple time zones and through extreme climates. Temperature ranges are defined by the choice of PCM and the specific temperatures at which they are designed to perform.

PCMs must be pre-conditioned prior to use (i.e. stored in a refrigerator or freezer for a specified period of time to replicate the desired temperature).

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Because of the sophistication of this packaging, units are typically rented by the shipper and are reused by the logistics p ro v i d e r, re d u cin g t h e e n viro n m e n t a l f o o t p r i n t . T h e y m u s t , h o w e v e r, b e inspected, cleaned and disinfected prior to each use. As vacuum panels become less efficient over time, they should be periodically replaced.

approximately eight liters and can only be used for single-use applications.

Proprietary data suggests that usage should be limited to 48 to 72 hours.

Pros • Compact size.

• N o n e e d f o r p r e - c o n d i t i o n i n g , refrigerators, freezers .

▪ Less warehousing space/packaging waste.

• Reduced shipping costs.

• Ease of use.

There should be collaboration between all parties including governments, customs agencies, law enforcement agencies, regulatory authorities, manufacturers, distributors and entities responsible for the supply of pharmaceutical products to patients to ensure the quality and safety Cons of pharmaceutical products and prevent • Limited capacity. the exposure of patients to counterfeit • A c c o m m o d a t e s o n l y + 2 ° c t o + 8 ° c pharmaceutical products.3 independently.

▪ P e r f o r m a n c e i n c o l d e r a m b i e n t Sourcing the Right Logistic Partner temperatures.

• Single use/negative environmental Packaging recommendation is only one of factor. many services provided by the logistics

Pros • Enhanced performance.

• S a m e P C M c o n f i g u r a t i o n s u m m e r / winter.

• Accommodates various temperature ranges.

• Reliable thermal performance that meets global/individual testing standards.

• High degree of security, protection.

• P o t e n t i a l f o r l o w e r f r e i g h t c o s t s (comparative weights of PCMs vs. gel-packs).

• M u l t i - u s e / r e d u c e d e n v i r o n m e n t a l Good Distribution Practices for footprint.

Pharmaceutical Products Cons • Maintenance, cleaning, disinfecting between use.

• Potentially costly if used as single-use application.

All parties involved in the distribution of pharmaceutical products have a responsibility to ensure that the quality of pharmaceutical products and the integrity of the distribution chain is maintained throughout the distribution process from Although consistently reliable, the site of the manufacturer to the entity pharmaceutical shippers should recognize responsible for dispensing or providing the that not all makes and models will perform product to the patient or his or her agent. equally over extended time frames or The principles of GDP should be included extreme climatic conditions. in national legislation and guidelines for the distribution of pharmaceutical products, Some smaller shipments may benefit from in a country or region as applicable, as a a packaging option that utilizes a push- means of establishing minimum standards. button technology to create a temperaturecontrolled +2°C to +8°C environment. The principles of GDP are applicable Benefits of these evaporative cooling both to pharmaceutical products moving systems may include lower shipping costs forward in the distribution chain from the due to their smaller size, weight and manufacturer to the entity responsible for profile. These units are also temperature- dispensing or providing pharmaceutical ready in minutes without the need for products to the patient and to products pre-conditioning; take up less storage which are moving backwards in the chain, space in the warehouse; and produce less for example, as a result of the return or packaging waste. recall thereof.

They offer only a limited capacity, however, accommodating a maximum payload of 16 January 2015

products which are donated. All entities involved in the distribution process should apply due diligence with adherence to the principles of GDP, for example, in procedures relating to traceability and in recognition of security risks.

provider. Regardless of how sophisticated the packaging selection, how short the duration of the transport, or how many times the provider has successfully delivered in the past, each shipment is unique.

Quite apart from the reliability of the packaging unit is the knowledge, training and geographical reach of the logistics staff who will handle the shipment. As noted above in the packaging descriptions, there are many variables associated with maintaining the required temperature over a period of time and a variety of external conditions. These variables include the appropriate conditioning of refrigerants; packing the unit to meet temperature specifications according to external temperatures and time of the year; temperature monitoring; in-transit interventions including replenishment of refrigerants, re-routing and after-hour services as required; incident reporting; and the effectiveness of contingency planning should unforeseen events occur.

Pharmaceutical shippers should ensure that they fully understand the capabilities The principles of GDP should also be o f t h e i r l o g i s t i c s p r o v i d e r s i n e v e r y adhered to in the case of pharmaceutical delivery location where they will require Pharma Bio World

Department of Pharmaceuticals Ministry of Chemicals and Fertilizers Government of India

Ministry of Health and Family Welfare Government of India

PHARMA SUMMIT

CHIEF GUEST

GUEST OF HONOR

Changing Dynamics the Road Ahead 18th February, 2015 • Hotel Le-Meridien – New Delhi

Shri Ananth Kumar

Hon’ble Minister Ministry of Chemical and Fertilizers Government of India

Dr. V. K. Subburaj

Secretary Department of Pharmaceuticals Government of India

INTRODUCTION he country's Pharmaceutical Industry accounts for about 2.4% of the global pharma industry by value and 10% by volume. Industry revenues are expected to expand at a CAGR of 12.1% during 2012-20 and reach USD 45 Billion. India's Generic drugs account for 20% of global exports in terms of volume, making the country the largest provider of generic medicines globally. The Generics market is expected to grow to USD 26.1 Billion by 2016 from USD 11.3 Billion in 2011. The formulation industry-India is the largest exporter th of formulation with 14% market share and ranks 12 in the world in terms of export value.

T

Market Trends and Opportunities: (According to DIPP) Between 2011 and 2016, patent drugs worth USD 255 Billion are estimated to go off patent leading to a huge surge in generic product and tremendous opportunities for companies. In 2011, India's OTC drug market stood at USD 3 billion and a rise to USD 6.6 Billion in forecast by 2016.

With increasing penetration of chemist, especially in rural India, OTC drugs will be readily available. Pharma companies have increased spending to trap rural markets and develop better infrastructure. The Market share of hospitals is expected to increase from 13.1% in 2009 to 26% in 2020. The purported rise of lifestyle disease in India is expected to boost Industry sales figures. Over USD 200 Billion is to be spent on medical infrastructure in the next decade. Rising levels of Education are set to increase the acceptability of pharmaceuticals. India's patient pool is expected to increase to over 20% in the next 10 years, mainly due to the rise in population. India is expected to rank amongst the top three pharmaceutical markets in terms of incremental growth by 2020. Cost of Production in India is significantly lower than that of the USA and almost half of that of Europe. Weighted tax deduction of 200% under Section 35 (2AB) of the Income Tax Act for both capital and revenue expenditure incurred on scientific research and development. Expenditure on land and buildings are not eligible for deduction.

However, having such a huge market and investment capacity, Indian Pharmaceutical Industry is facing certain challenges of business viability and regulatory control over a couple of years and due to this the Growth of Industry may not reach up to the mark as anticipated.

Challenges currently being faced by the Industry

Objectives of the Summit

Clinical trials – amendment in compensation guidelines and approval process. Drug Price control regulations by NPPA. The imbalance between control and decontrol basket will have far reaching implications on investment the in Pharma Sector.

The objective of this summit is towards creating a platform for discussing the various issues and to streamline the Regulatory framework and imparting more practicability in the Government policies. To converge all the senior officials from the Union Ministry, State Health Senior Officials, Health Policy makers, Pharmaceutical industry leaders, Clinical Experts, Researchers at a common platform to converse about the best practices which can be implemented to provide a smooth environment for both the private and government officials. To encourage the excellence and innovations and to promote the employment in the pharmaceutical industry.

Non Conducive environment for innovations and IPR because very low spending on Research and Development by Pharmaceutical Industries. All of the above challenges are the main reasons for the unviable business environment and rising unemployment in the Indian pharmaceutical sector.

Participant Profile • Senior Officials from the Union Ministry of Health and Family Welfare • Senior Officials from the Union Ministry of Chemical and Fertilizers • Senior Officials and Directors from the Health Ministry of the various states • Senior officials from the DCGI. • Senior officials from the FDAs of the States.

• Senior Drug controller from the center and the States.

• Senior officials from the NPPA. • CEOs, CMOs and Regulatory affairs experts from the Pharmaceutical Industries.

• Researchers and Scientists from the Pharmaceutical Industries.

• Heads of the Clinical trials division of the Pharmaceutical Industries.

• Heads of the Government affairs division of the Pharmaceutical Industries.

• Senior officials from the ICMR, CSIR and DBT. • Other stakeholders related to Healthcare.

The Associated Chambers of Commerce and Industry of India

5, Sardar Patel Marg, Chanakyapuri, New Delhi-110 021 • Tel: 011-46550555 (Hunting Line) Fax: 011-23017008, 23017009 • Email: assocham@nic.in • Website: www.assocham.org

Participation Fee: Rs. 3,000/SUPPORTING PARTNERS

MAGAZINE PARTNERS

For further details, please contact:

Bharat Kumar Jaiswal

M: +91-9971047550 E: bharat.jaiswal@assocham.com

Karanveer Singh

M: +91-9560372937 E: karanveer.singh@assocham.com

service. Although shippers are certainly not expected to know every last detail relating to the transport, they should have confidence that trained personnel can and will take remedial action anywhere in the world it may be required. Whether that means reverting to an alternate routing to dodge incoming weather in London or switching out failing gel- packs during an overnight delay in Bangalore, the logistics provider must demonstrate that its staff has the knowledge and flexibility to manage high-value shipments each and every time and intervene when necessary.

Reverse Logistics in Pharmaceutical Industry It denotes all those operations related to the reuse of products and materials. The reverse logistics process includes the management and the sale of surpluses, as well as products being returned to vendors from buyers. Reverse logistics stands for all operations related to the reuse of products and materials. It is “the process of planning, implementing, and controlling the efficient, cost effective flow of raw materials, in-process inventory, finished goods and related information from the point of consumption to the point of origin for the purpose of recapturing value or proper disposal

With ever-changing regulatory requirements associated with healthcare products, experts emphasize the importance of pharma companies to ensure all aspects of drug recalls and returns are handled safely and costeffectively. While the reverse side of the supply chain typically represented only 1 to 2 per cent of total sales, i n a s u ff e r i n g e c o n o m y, e v e r y p e n n y counts. These and other factors are reportedly leading to additional emphasis being placed by reverse logistics providers on environmentally benign disposal practices.

These companies claim they are well positioned to take all of the necessary steps involved in collecting and recycling of drug packages sent back to the manufacturer as a result of either recalls (where there is an FDA-mandated, or manufacturer-originated, retrieval of already shipped product) or returns (when out-of-date product is sent back to the manufacturer by agreement) to ensure an environmentally safe method of recovery.

On the packaging side of the pharma business, environmental solutions are being developed that enable drug makers to reuse containers, saving them money

and minimizing waste. A case in point is Entropy Solutions (Minneapolis), which o ff e r s a r e v e r s e l o g i s t i c s m o d e l t h a t ensures a pharma customer’s purchased or leased temperature-management shipping system significantly minimizes packaging waste and drives down shipping and logistics costs. The Greenbox line features a reusable design which is said to provide customers with up to 100 times of reuse, and created with 100 per cent recyclable, organic-based, non-toxic and fully biodegradable components.

While a large component of handling a drug recall is the physical processing and disposition of the product, even more important is tracking and information exchange of the recall data. Extensive government regulations and reporting requirements, along with an increased focus on pedigree, have increased the need for good tracking, visibility and control measurements, industry watchers say. These are all critical components for any reverse logistics process.

Indeed, companies specializing in handling drug product returns and recalls concur they are well positioned to handle every aspect of reverse logistics, including notification and response, processing and tracking, compliance and reporting. As we all agree, “Time is Money”.

References: 1) Omer Abdullah, SIG, Newsletters, Key Trends in the Pharmaceutical Supply Chain.2014.

2) Andreas Kjä llander, Nils Markmann, Temperature Control and High-Value Shipments, worldcourier.com. 2014.

3) W o r l d H e a l t h O r g a n i z a t i o n , W H O Technic al Report Series, Annex 5, WHO good distribution Practices for pharmaceutical products, No. 957, 2010.

Contact: madhusudan.d@richcoreindia.com

18 January 2015

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Supply Chain Challenges to Pharmaceutical Industry Supply chain challenges are on the rise each day due to rising costs of hospital upkeep and outbound logistics involving warehousing and distribution network of pharmaceutical industries who are busy on 24/7 basis to fulfill the critical demands raised by the state of the art hospitals in the globalized environment . The criticality and complexities of the healthcare sector cannot be overemphasized. But the good news is that with the systematic approach of supply chain concepts blended with technology, the challenges can be met seamlessly.

H

ealthcare sector is one of the largest and fastest growing sectors in the world. For this phenomenal growth, the prominent key drivers and the rising challenges are; - Globalization and the advancement of information and communication technologies.

- Patient safety and security.

- Complexities in the supply chain due to rising demands from hospitals for pharmaceutical industries.

Supply chain management techniques which have successfully been employed almost throughout the segments of Industry are employed in health care sector also to face the above challenges.

Like other segments, here also these techniques have successfully been employed to match supply and demand so as to supply the material in the right quantity, at the right place t right price, right product and most important at the right time.

Supply Chain Management in Pharma Industry and Hospitals A popular notion is that supply chain concepts can be applied largely to manufacturing operations and are not applicable to service operations. But this is not true. Like every Enterprise, hospitals and health systems are equally under pressure to control their rising costs of supplies primarily locked up in inventories c o n s i s t i n g o f p h a r m a c y, s u r g e r y, medicines and drugs and yet maintain their ultimate obligation in providing timely, efficient and effective treatments to their customers (patients).

Akhil Chandra Professor - Logistics and Supply Chain Management, ICRI Okhla, New Delhi 20 January 2015

The supply chain costs represent today the second largest expenditure category of hospital’s operating expenses next to costly manpower. These costs are increasing exponentially due to –

• Growth in usage of medication and very expensive and very clinically sensitive devices and implants.

• Service lines, such as interventional cardiology and total joint replacement surgery, using high value supplies such as supplants and drug coated stunts.

• The rise in IT budgets at healthcare institutions.

• Increased cost of drug development, production and distribution.

• C o s t o f p a c k a g i n g a n d l a b e l i n g requirements of Drugs.

It is as such important to have a close look on supply chain management system of hospitals with an Endeavor to make it efficient, integrated and synchronized. The subject popularly known as HSCM (Hospital supply chain management system) due to its potential in saving heavy costs and in satisfying patients has gained its prime importance in healthcare industry. Senior financial executives as such these days need to recalculate the strategic significance of the supply chain and plan accordingly.

Inefficiencies in supply chain unlike in other domains of industry may result in extreme cases even into death of patients.

As such apart from cost reductions, an effective supply chain is very vital to human life and its longevity. Ultimate objective of this subject is to manage materials/equipments and manpower like doctors, nurses and other supporting staff and treat patients and transform them into a healthy person at a reasonable and optimum cost in minimum time so as to satisfy their expectations through quality treatment. Innumerable flows between suppliers and customers, both upstream and downstream, have to be considered to strike a balance.

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Supply Chain of Hospitals Supply Chain (also can be characterized as value Chain) of hospitals integrates suppliers, transport and warehouses and hospital services (including outpatient, e m e r g e n c y, i n - p a t i e n t , l a b o r a t o r y, radiology, stores and purchase, food, laundry and medicines /equipments) so as to serve the patients by optimum utilization of resources. The resources in terms of materials/medicines used in the hospital can be classified majorly based on their applications such as diagnostic, Surgical, Therapeutic, Bedside, Service, Engineering, Housekeeping and ICT. To substantially reduce supply-related costs, a hospital must develop a fully integrated enterprise wide supply chain in which all processes as mentioned above are coordinated and supported by state-ofthe-art technology. A pertinent question which should be asked to hospitals is whether your organization delivers the right product to the right place at the right time and for the right price? If not then situation demands for a thorough check up of your processes and give your hospitals a treatment of ‘Supply Chain Management’.

Basically the process improvement opportunities exist in five key areas; 1) Contingency plans.

“Like Healthcare supply chains need to move toward an integrated ‘demand-pull’ model, so that manufacturers have much earlier visibility into actual consumption.”

2) Supply chain integrity.

3) Demand pull model.

4) Cutting down on too many intermediate partners.

5) Value visibility.

Contingency Plans As the supply chain involves factories producing medicines and diagnostic equipments, temperature controlled warehouses and distribution facilities to keep the material flow in order, what happens if a factory producing lifesaving medicine gets destroyed or the distribution facilities disruptions hamper the product flow endangering human life?

The most effective action is to develop systematic contingency plans, including factors like alternative production sites, manufacturing flexibility, factory-direct s h i p p i n g c a p a b i l i t i e s , o ff s i t e b a c k u p distribution center capacity, and critical safety stocks.

Supply Chain Integrity Quality assurance, such as lot integrity and tracking, is a crucial healthcare

supply chain function. It ensures that patients receive safe therapies, and that problems are contained and minimized.

New technologies, such as radio frequency identification (RFID), offer the prospect of ensuring supply chain integrity. Through automatic identification, traceability and visibility tools, healthcare companies are given the opportunity to make the Healthcare supply chain more efficient and accurate, and thus safer by; • Reducing medication errors.

• Making counterfeiting more difficult.

• E n a b l i n g e f f i c i e n t a n d e f f e c t i v e traceability.

• Decreasing the production and supply chain cost.

It is important here to mention here that revolutionary technology of RFID can greatly contribute to the healthcare and pharmaceutical industry with Wi-Fi and voice over IP (VoIP), creating a single information system providing visibility throughout the supply chain. It track patients and hospital assets, improve patient safety, play a role in running clinical trials of drugs, manage critical care assets and hospital equipment, reduce counterfeiting of pharmaceutical products, reduce medical errors, and cut costs, thereby improving efficiency.

As a futuristic technology I would like to mention that in future unmanned flying vehicles as drones through aerial route would provide speedy delivery of critical items like blood, medicines appliances to the hospitals enabled by the pharmaceutical firms. This would improve to fulfill the critical demands posed by hospitals on pharma industry towards patient life safety enabling doctors

22 January 2015

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in performing critical operations in the operation theater.

Demand Pull Model Healthcare supply chains need to move toward an integrated ‘demand-pull’ model, so that manufacturers have much earlier visibility into actual consumption. In many other industries, this integrated supply chain system has enabled the participants to align production and distribution much more closely with actual demand. All the channel participants can see and understand what they need to do individually and together in order to successfully lower costs and increase service levels.

Healthcare supply chains would free up tremendous amounts of valuable resources by adopting this channel model; important elements, such as ICT and process control systems to provide real-time information at point of patient infusion/injection, are now being put in place.

Cutting Down Intermediate Partners The prospect of disintermediation, moving product directly from manufacturers to providers, is growing stronger in healthcare supply chains. This process offers important economic benefits. But it is only appropriate in certain situations, and it requires that manufacturers and providers develop new expertise and trust.

To give a successful example from other segment of industry, Wal-Mart and Proctor and Gamble built a strong and sustainable relationship between them and the rewards were in terms of win-win situation for both of them to become world leaders in their respective areas.

Value Creation by Individual Partners At present health care supply chains are fragmented and the current pricing Pharma Bio World

structures and channel policies reinforce the inefficiency of this fragmented sector.

Distributors negotiate volume discounts from manufacturers, and offer discounts to providers. What is important is to have trust in each partner and work towards common goal of value creation, which is the precondition for major improvements in supply chain efficiency.

In well-functioning supply chains, each participant has an important role in creating unique, visible value as product flows from source to consumption. Instead of competing within the value chain, one supply chain of the hospital should compete with another value chain of the hospitals for sustainability, survival and competitive advantage.

Conclusion Supply Chain Management in other industries has got its due recognition and this subject now is considered to be a board level topic to solve intricate and new challenges rising in this critical segment. Now conditions are right for another round of major healthcare supply chain improvements due to

pressure on management to reduce costs and increase efficiency and have a customer responsive approach. This has happened especially after hospital chains of multinationals have arrived in India.

Healthcare budgets are very tight, supply chains have critical vulnerabilities, and providers have significant opportunities for much-needed process improvements.

The supply chain as such should be part of the enterprise strategic plan, incorporated across all components and service lines of hospitals.

A hospital’s or health system’s strategic plan should include supply chain management as a key strategy for maintaining fiscal goals, improving quality and satisfaction levels, and addressing industry trends and developments.

There is a tremendous scope of applying IT, telecommunication techniques and Automation in hospitals. The mantra is to concentrate on improving efficiency, quality, and responsiveness to patients and apply innovative methods of supply chain coupled with technology to achieve the end goals.

Contact: akhilchandra06@gmail.com January 2015  23

Leveraging Mobility for the Life Sciences Industry This article describes how life science companies can leverage the significant innovations in mobile devices to attain the operational efficiencies, achieve competitive advantage and improve patient care.

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ndia is rapidly advancing in mobile technology adoption for individual and business needs. TRAI claims a figure of 933 million users of mobile phone, the advent of low-price smartphones and cutthroat price competition in internet tariffs might bring more users to use internet and the country may become highly tech and net-savvy. Experts believe India may have more than 300 million Mobile Net Users by 2016 driven by falling handset costs, higher smartphone penetration, faster bandwidth and higher internet content or online services.

The Enterprise mobility solution is transforming the way by which we do business. Applications are being develop to reduce turnaround time by capturing data at the point of action either in the field or within premises. There are cases where organizations have added additional channels for customer interaction and revenue stream. Enterprises are in the process of adopting this mobile revolution to be highly competitive in the market place.

Organizations find many advantages by using these newer technologies; • Complete on-time delivery.

• Improvement in time to decide.

• Amount of work time spent on trying to access data.

• Inventory accuracy.

• Cycle time between service completion and invoicing.

The Life Science Industry has adopted these technologies to benefit its operations in terms of bringing out drugs faster to the market, maintaining the quality of drugs, reducing the cost of operations and achieving improved compliance to regulations.

Life Sciences Industry: Challenges & Opportunities Govind Srinivasan Vice President – Delivery Technology Group, TAKE Solutions 24 January 2015

The Pharmaceutical industry is experiencing unprecedented amount of challenges due to

a large number of patent expiry, high cost and long lead time to bring out new drugs, pricing regulations, global competition, regulatory norms, stringent quality protocols, etc. The regulatory authorities have become very stringent on deviations and are subjecting all manufacturers to strict quality norms. Pharma companies are taking every effort to improve efficiencies in all steps of clinical trials, inventory, manufacturing, packing and distribution.

Regulatory requirements force pharma companies to have a lot of records which are often collected manually and reentered into the system.

Clinical Research Many organizations are required to plan and execute clinical research in a rapid and cost effective manner so that risks and complexity of trials are effectively addressed. Some areas of clinical trials are still performed based on paper systems along with manual data entry. R&D being a major investment area has a number of opportunities for improvements and optimization using new technologies.

Mobile applications can assist proactive planning of site visits and recording of site visit details into a Clinical Trial Management System. This will shorten study cycle times by obtaining and delivering higherquality data more quickly, and reduces development costs by maximizing the produc tiv ity of monitor in g r e s o u r c e s .

It also promotes compliance to site monitoring requirements.

Manufacturing & Warehouse Most Pharma manufacturers have implemented manufacturing/packaging line management automations and backend ERP applications. The major area of weakness is integration such as manPharma Bio World

and the same can be analyzed further.

It helps the manufacturers to ensure the identity, potency, purity, quality and safety of product.

Sales & Marketing

machine integration, manual operation & its verification, automated data collection, and B2B to suppliers & distributors.

Digital Warehouse

With the Enterprise mobility system, a Digital warehouse can be created in Some key challenges typically faced by which all the warehousing operations are controlled electronically. The users can many pharma companies are: • Automating integration with suppliers perform the operations like receiving, putfor managing and controlling supplies away, sampling, picking, goods issue and inventory transactions using RF devices in & labeling of raw materials.

• D i s p e n s i n g o f r i g h t i n g r e d i e n t s t o the shop-floor, to improve throughput and productivity. The captured informed can manufacturing lines.

• Dispensing right quantity of ingredients be updated Real-time into an ERP system. after considering the exact propensity Electronic Batch Manufacturing Record of material.

• Ensuring compliance of all designed manufacturing process and control Electronic Batch Manufacturing Record captures all the process parameters and checks with appropriate escalations.

• C r e a t i n g a n d m a i n t a i n i n g b a t c h ensures compliance to the regulatory requirement. Mobility solution can capture manufacturing records electronically.

• Controlling final product labeling so that the data at the point of action and validate whether the process parameters are as it matches with the packaged drug. per the Standard Operating Procedures The mobility solutions can be deployed to ( S O P s ) . I t c a n a l e r t t h e c o n c e r n e d effectively address some the challenges if there is any deviation. Integrated Equipment provide an error free data highlighted above.

“With the Enterprise mobility system, a Digital warehouse can be created in which all the warehousing operations are controlled electronically.”

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Many organizations are looking into multiple channels of interactions with the customers and the information/interactions should be consistent across all channels.

These channels also give useful insights to the organizations to position the products well and get feedback from customers. The interactions with prescribing doctors are also critical for promoting their products.

Medical Representatives need to effectively explain the drug information to the doctors and answer their queries in meetings lasting for a short duration of time.

Marketing Using Tablets Mobile CRM solutions in tablets allow medical representatives for innovative and engaging ways to communicate product information to doctors, without having to worry about incorrect information. They can also demonstrate clinical articles or patient videos and other important information.

Sales force effectiveness like the view time of physicians can also be monitored effectively.

Distribution Drug Distribution through the supply chain to reach the consumer is normally complex and highly regulated. In case of cross border distribution, additional documentation including transaction history of the consignment are required to maintained at least for ten years. For some drugs the distribution channel has to plan for controlled temperature transportation and short expiration timelines.

Mobile Route Accounting applications can assist mobile warehouses, usually trucks, operating as direct store distributors, January 2015  25

to capture and record the transitions in real time. It can help to automate the distributor â&#x20AC;&#x2122;s daily activities as well as provide data consolidation of the transactions.

Today, mobile applications are becoming critical to success of an organization. It is important for IT/ Business heads to identify the areas having major impact on business for automation. This will enable the power of the back-end ERP systems to be available at the fingertips of the actual executioner and avoid any time delay of recording the transactions. Another major advantage of these applications is enforcement of controls required for operating with optimal efficiency. Organizations are reinventing by adopting newer ways of working and should adopt these technologies fast to avoid any impact on competitiveness.

Contact: jananee.gangadhar@2020msl.com

26 ď&#x201A;&#x192;January 2015

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Air Cargo in Indian Pharmaceutical Industry Pharmaceutical air freight needs the establishment of complex logistical methods to maintain shipment’s integrity. It requires strict temperature control, harmonized handling procedures and other ambient storage technologies to ensure maintaining the quality of a pharmaceutical product throughout the distribution process.

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he air cargo industry in India is currently witnessing a dynamic phase of development and has the potential to become an international air freight hub in the future given India’s domestic market size and geographic location. Volumes in the air cargo industry have seen stable and consistent growth and although there are already efforts to upgrade cargo handling facilities, more needs to be done for supporting infrastructure to match. Ind-Ra (India Ratings and Research) has predicted a stable outlook for pharmaceutical companies and a world-wide increase in pharmaceutical and life science shipments especially in terms of exports. Moreover, with the recent changes in health care policies, Indian pharmaceutical companies will be focusing more on exports to the US, Europe and Africa markets and this will certainly provide further impetus to the growing air cargo industry.

With India working earnestly to become the global pharmaceutical manufacturing and processing hub, it is imperative for the relevant infrastructure and logistics for pharmaceutical handling to improve in tandem to support this ambition.

Willy Ko CEO Air India SATS Airport Services Pvt Ltd (AISATS) Pharma Bio World

Air Cargo in Indian.indd 27

Air logistics is the lifeline of the Indian pharma industry, and transporting healthcare products by air needs the establishment of complex logistical methods to maintain the shipment’s integrity. It requires specific equipment, storage facilities, harmonized handling procedures and, above all, strong cooperation among the cold chain partners.

While infrastructure for airfreight terminals at key airports are being put in place, more needs to be done to meet the exacting demands of pharmaceutical product handling and to manage the growth we are expecting to see in the coming years.

The pharmaceutical industry by itself is becoming increasingly diverse, fuelled by ageing populations, emerging markets

with their growing middle classes, along with innovative technological platforms.

Constant monitoring of pharmaceutical products is key to their transportation and to minimize damage and losses while shipping. Ensuring that the required storage conditions for pharmaceuticals products are maintained during the various stages of the handling is equally important.

It is estimated that by 2016 more than half of the top 50 best-selling drugs will require cold chain transportation, according to the Bio-pharma Cold Chain Sourcebook 2013.

Cool-chain facilities at airports that are essential for shipping pharmaceutical goods, require appropriate infrastructure and regulatory policies to ensure that such products are handled expediently and safely. Moreover, it is important to ensure the fast movement of these goods in the cargo terminals with timely regulatory clearance for delivery of the products.

In April 2013, the Revenue Department had instructed customs officials to accord “speedy clearance” to perishable agro items. There is also an increasing need for more warehouses equipped with temperature controlled systems and transportation processes to enhance the freight services provided both to pharmaceutical companies and their customers. The entire cool chain, right from the gates of manufacturing plants to the air freight cargo terminals to the distribution/processing centers and to the shelves at the stores/shops, need to be supported and managed properly.

A break in the chain would pose risk to the quality and reliability of the pharmaceutical products. Having proven to the world that India is good and reliable in the manufacturing of pharmaceutical products, there is now a need to demonstrate that we can similarly process and deliver these products to the end customers safely and January 2015  27

22-01-2015 15:51:21

in accordance with the delivery demands of the customers. These are some areas which need more nurturing and appropriate policies to support and encourage worldclass handling.

Stakeholders in the pharmaceutical logistics industry are faced with the daunting task of catering to a burgeoning industry that needs to be supported by efficient logistics. A critical challenge that the pharmaceutical logistics industry needs to overcome in India is power supply.

The storage of these products needs uninterrupted power supply. Therefore, power failure contingency plans are also critical to successful pharmaceutical logistics in India.

With the global growth seen in the pharmaceutical industry it is important for all stakeholders to conform to industry standards so as to safeguard public health.

“With the recent changes in health care policies, Indian pharmaceutical companies will be focusing more on exports to the US, Europe and Africa markets and this will certainly provide further impetus to the growing air cargo industry.”

The World Health Organization’s guidelines for Goods Distribution will be able to bring the pharmaceutical logistics industry onto the same page as maintaining product safety and quality is of utmost importance in the pharmaceutical industry.

The Bangalore Airfreight Terminal facility o f A I S AT S r e c e n t l y r e c e i v e d i t G o o d Distribution Practices (GDP) certification which is a quality system that ensures that the quality of a pharmaceutical product is maintained throughout the distribution process. With this certification, AISATS demonstrates its commitment to providing world-class and industry-recognized quality

standards in every aspect of its facilities and services.

In conclusion, it is imperative to gear up to meet growth opportunities in the industry and work towards further improving facilities for pharmaceutical cargo. Going forward, we expect to see more initiatives undertaken to the build specialized perishable handling centers and automated tracking solutions to optimize shipment processes and provide smooth and safe transportation services to the pharmaceutical industry.

Contact: balamanda@perfectrelations.com

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28 January 2015

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22-01-2015 15:53:40

Disparity in FTE Rates - A Significant Driver for Discovery Research Services in the Emerging Markets Sourcing managers are tasked to generate significant cost savings across core spending areas such as chemistry services, biology services, in-vitro & in-vivo testing. Addressing such a business issue requires one to take a closer look at the chief cost constituent “Labor/Personnel“ & have a greater understanding of its impact on the final list price for any particular service rendered.

Given the fact, that most outsourcing contracts with emerging market vendors ,are signed on “Full-TimeEquivalent” models .This article would endeavor to present the different dynamics involved in FTE billing rates, type of vendors & their decision surrounding profit margins.

D

rug Discovery services in the emerging regions - India, China & Eastern European countries such as Hungary, Ukraine is expected to witness growth rates in the range of 5 - 8 per cent in the next three years.

Albeit, there is an apparent focus on late stage assets & increased pipeline rationalizations among top R&D spenders, outsourcing of routine /process oriented testing services especially in the discovery chemistry segment - Medicinal chemistry ,computational chemistry & chemical synthesis continues to increase.

Ostensibly, the service providers based in the afore mentioned regions have been known to operate at the relatively lower FTE rates & thereby attract new customers and retain clientele. Sourcing managers are curious to comprehend how are various suppliers able to operate at lower FTEs rates? Is there a huge disparity in rates observed in the developed regions of Western Europe, US vis-à-vis developing regions? What are the average profit margins at which vendors operate?

Pharma Bio World

Disparity in FTE rates _Submission Copy.indd 29

Market Trends India, China & Eastern European countries are the regions that are most preferred offshoring regions for both chemistry and bio analytical work.

• The general outlook for early phase outsourcing ( Drug discovery services – preclinical testing ) is expected to be low, as large section of R&D budgets are being apportioned to late stage or closer to approval assets/compounds in the value chain and hence low growth rates for the near future.

Drivers for India & china would be the following;

The chief constituents of an FTE rate are employee costs, equipment cost, administration & the net profit margin. The proportion of each of the cost components along with a typical hierarchy for dedicated resources & various technologies are depicted in Figure 1.

• Reverse brain drain – Experienced CRO scientist experienced in the west, retracting to their home countries.

Therefore addressing, perception surrounding, quality.

• Routine /process intensive functions such as custom synthesis, libraries management, etc have been addressed to by CROs based in these regions to the expectations of clients as opposed to proprietary /innovative research.

• Global players having captive centers to take advantage of the cost arbitrage.

Why there is disparity in FTE Rates?

Conclusion

Majority of the service vendors continue to adopt the “Cost + Margins” model, therefore a direct proportionality relationship exists between cost centers & the final billing

Disparity in FTE rates for chemistry and allied services will continue to remain an important factor, when it comes to outsourcing decisions.

The FTE Break Down - Discovery Chemistry Services

C Vivek Senior Domain Lead – Pre-clinical services, Beroe Inc

rate. Prominent vendors have been known to operate at higher margins and hence their quoted FTE rates to clients is significantly higher (multiplying factor of 11/10 or 6/5 on the average FTEs rate of USD 35000 -40000).

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~40%

~30%

Employee Cost Director Lab Manager Senior Chemist Junior Chemist Trainee Chemist

Instruments

Lab Maintenance & Certification

~30% Infrastructure Overheads

Net Profit

HPLC/MS Nuclear magnetic resonance Karl Fisher Titrator Differential Scanning calorimetry Supercritical Fluid Chromatography

Composition of dedicated resources for a program. Senior & junior Chemists constitute ~90% of resources.

Profit margins are highly variable .Wage inflation, costs of equipment & going rates in the market have a significant impact on margins.

Sampling of technologies available in the market.

20 %

10 %

Established Vendors

New entrants

30 %

30 %

Margins made by firms in India has markedly reduced when compared to the 2008-2010 period range of 35 -40%.The current margins range between 15-18% and certain firms have known to receive incentives based on the percentage of savings made by their clients.

Figure 1 / Source: The above statements have been derived from interactions with CEOs of chemistry service providers based in India & Europe

Decision Framework – Vendor Organization

Pre – Negotiation Recommendations for Category Managers: > Vendor pre-qualification RFQ/RFPs to probe on academic qualification and experience of resources. > Micro market scans for going rates (CTCs/ Salaries) for varying experience & academic qualifications. > Probe on type of equipment’s housed & if resources are shared or dedicated to a single program. > Track regional macroeconomic indicators for wage inflation trends especially for long term or strategic engagements.

Employee Salaries

Equipment

There is a greater propensity among tier 2 and new vendors to deploy a greater percentage of the lesser experienced staff who command lower annual salaries. Willingness to operate at lower operational margins <=10% is also high to attract clients. This type of operational model is prevalent among spin-offs of major vendors who specialize in one or two functions such as chemistry synthesis, medicinal chemistry & less prevalent among established vendors.

Decision to either out rightly purchase equipment with significant capital outlay or lease the required technologies can also majorly impact service charges. Utilization rates of these equipment’s & shared practices can also influence prices.

Figure 2 / Source: The above statements have been derived from interactions with CEOs of chemistry service providers based in India & Europe

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N=13 quotations from various tier of suppliers. The rates are can vary depending on the inclusion of standard & special reagents.

Source: The above figures were derived from job portals

Key Market Indicators & Prominent Vendors - India & China Market Indicators

India

China

Market Growth Rate

~5% (next 3 years)

~6%

Inflation Rate

~6%

2.5%

Wage Rate

~12%

-

FTE range

EUR 31000-61000

EUR 45000-75000

Key Vendors

Jubilant, Piramal, GVK Bio,Suven Life Shanghai Medicilon, Shanghpharma, Wuxi Apptech, Sundia Meditech Sciences.

The last couple of years have been rewarding for vendors based in India & China. Emphasis on service offering integration across & within mainstream functions, namely chemistry & Biology have been observed, with notable cases being Wuxi Apptec, Jubilant, Suven, Enamine.

The global market is highly fragmented, and suppliers will seek to leverage cost differentiation to stave off competition.

In fact, some service providers are also exploring options of making investments in tier 2 cities in their respective countries to optimize costs of delivery.

I n i t i a t i v e s o n th e b u ye r ’s f ro n t t o b e updated on the supplier landscape, changing price regimes and related market t r e n d s w i l l e n s u r e e ff e c t i v e s o u r c i n g Pharma Bio World

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decisions, eventually adding value and bringing down costs.

Disclaimer The contents of the paper have been derived from interactions with service providers and consultant’s in the field. The objective of the paper is to educate the reader on current market developments with suitable illustrations and not to recommend/ advice on sourcing decisions.

h t t p : / / w w w. i n d i a - b r i e f i n g . c o m / n e w s / average-indian-salary-to-increase-by10-percent-in-2014-7933.html/Inflation rates : Bloomberg Contact: vivek_c@beroe-inc.com

References: h t t p : / / w w w. s e l v i t a . c o m / p l / i m a g e s / p d f / chemistry%20and%20integrated%20 services%20in%20emerging%20 countries.pdf http://www.tradingeconomics.com/unitedkingdom/labour-costs January 2015  31

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market research

Type 2 Diabetes Therapeutics: A Highly Competitive and Growing Market Type 2 diabetes treatment market value in Asia-Pacific (APAC) will rise from an estimated USD 6.5 billion in 2013 to USD 10.5 billion by 2020. The increasing diabetic population in India and China is the major reason behind the diabetes treatment market growth in the APAC region.

T

he market for type 2 diabetes contains a wide range of drugs that are used to treat patients at different points in the treatment algorithm.

The market landscape is dense, with a number of drugs competing for different market segments. Although the first-line therapy is usually metformin, a generic drug, it is often unable to bring the disease under control.

Second-line therapy involves the use of other drugs in combination with metformin, and at this stage of the treatment algorithm competition between products is very strong. The established second-line therapy involves the use of

sulfonylureas, a highly generalized class of drugs, in combination with metformin.

The usage of this class of drug is likely to decline in future, due to the recent approval of superior products and the anticipated approval of stronger products over the 2013–2020 forecast period.

The value of the market for type 2 diabetes in the Asia-Pacific (APAC) markets (for the purposes of this report, APAC refers to Australia, China, India and Japan only), is expected to increase from USD 6.5 billion in 2013 to USD 10.5 billion in 2020 at a Compound Annual Growth Rate (CAGR) of 7.1 per cent. This strong growth is due to the anticipated

approval of products in relatively novel treatment classes, such as GlucagonLike Peptide-1 (GLP-1) agonists, Dipeptidyl Peptidase-4 (DPP-4) inhibitors and Sodium Glucose Transporter-2 (SGLT-2) inhibitors; and the growth of the type 2 diabetes prevalence population in the APAC region, especially in India and China.

Among the four APAC markets, Japan has the highest market share of 51 per cent followed by China with 30 per cent and India with 14 per cent. In a bestcase scenario, the total market size is expected to grow at a CAGR of 8.1 per cent to USD 11.2 billion by the end of

Figure 1: Type 2 Diabetes Market, Asia-Pacific, Market Size (USD bn), 2013–2020 Source: GBI Research, Proprietary Pipeline Products Database; GBI Research, Proprietary Marketed Products Database

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market research

Figure 2: Type 2 Diabetes Market, Global, Research and Development Pipeline (%), 2014 Source: GBI Research, Proprietary Pipeline Products DatabaseCTA: Clinical Trial Application; IND: Investigational New Drug

2020, while in a worst-case scenario it is expected to grow at a slower CAGR of 6.6 per cent to USD 10.2 billion by the end of 2020. Should the expensive drug classes mentioned above capture substantial market shares, market growth would be even more robust.

Strong Pipeline Containing a Diverse Set of Products The pipeline for type 2 diabetes contains 591 products, distributed relatively evenly between the different stages of development with the exception of the Preclinical stage, which accounts for 42 per cent of the entire pipeline.

20 products have been identified as being in the registration process for marketing approval, although many of these are Pharma Bio World

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novel formulations or combinations of existing products, and are not expected to influence the market to a great degree compared with entirely novel products.

Six late-stage pipeline products are expected to be launched during the forecast period, such as dulaglutide, albiglutide, trelagliptin, and tofogliflozin.

The active pipeline molecules, which amount to 591, consist of the following: • Discovery Phase: 14 per cent or 83 molecules.

• Investigational New Drug (IND)/ Clinical Trial Approval (CTA)-filed Phase: 1 per cent or four molecules.

• Preclinical Phase: 42 per cent or 248 molecules.

• Phase I: 14 per cent or 84 molecules.

• Phase II: 15 per cent or 988 molecules.

• Phase III: 8 per cent or 46 molecules.

• Pre-registration: three per cent or 20 molecules.

• Undisclosed: three per cent or 18 molecule.

There are six more molecules that are only available in part of the APAC region but that are expected to be launched in the remaining countries during the forecast period, such as lixisenatide, which is marketed in Australia but has not yet been approved in India, China and Japan.

However, the new pipeline does not include any novel Mechanisms of Action (MoA) and is dominated by drug MoAs that have already been marketed, such as SGLT, DPP-4, and GLP-1 receptor agonist.

Courtesy: GBI Research January 2015 33

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market research

Drug Launch and Phase 3 Trial Watch List for Top Therapeutic Areas Oncology, autoimmune and infectious diseases/vaccines are hot areas for novel therapeutics and in vitro diagnostics in 2015.

T

he therapeutics market is buzzing with activity, as several promising therapies are progressing to Phase 3 clinical trials and many more are awaiting commercial launches. As more complex specialty products are launched, the spending on personalized medicine will grow beyond oncology into areas such as infectious diseases (virology) and cardiology.

Frost & Sullivan examined promising therapeutics for 2015 finding that oncology, cardiovascular,autoimmune/antiinflammatories, and infectious diseases will be the top areas of investments in 2015.

“In addition, pharmaceutical companies will be keen to invest in in-vitro diagnostics such as biomarkers; molecular, tissue, companion diagnostics; predisposition disease; and predictive testing,” said Frost & Sullivan’s Healthcare analyst. “This is because drugs with companion diagnostics are expected to increase two- to three-fold over the next five years with increased focus on areas such as cardiology and inflammatory diseases.”

Therapeutics’ Watch List for 2015 1) Puma Biotechnology’s tyrosine kinase inhibitor, neratinib, for breast cancer adjuvant therapy: In its Phase 3 ExteNET trial, neratinib demonstrated significantly higher disease-free survival rates compared to placebo after adjuvant treatment with Herceptin (trastuzumab) for early-stage HER2-positive breast cancer. This therapy is awaiting Food and Drug Administration (FDA) filing in the first hald of 2015, and potential approval and launch in the second.

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2) Bristol-Myers Squibb’s PD-1 immune checkpoint inhibitor, nivolumab, for previously treated advanced melanoma patients: In its Phase 3 trial, CheckMate-066, the primary endpoint of overall survival (OS) was met. It emerged that the one-year survival rate was 73 per cent for nivolumab against 42 per cent for the chemotherapy, dacarbazine (DTIC) in patients with treatment-naïve BRAF wild-type advanced melanoma.

The Prescription Drug User Fee Act (PDUFA) has set the likely date for FDA approval as March 30, 2015. This could translate to a launch in the second quarter of 2015.

3) Novartis’ selective IL-17A inhibitor, secukinumab, for the treatment of plaque psoriasis: The Phase 3 trial drug, FIXTURE secukinumab, was shown to be significantly more effective in clearing skin lesions than Pfizer’s Enbrel. In October 2014, the FDA’s advisory committee recommended approval for secukinumab. Anticipate a successful product launch in the first quarter of 2015.

4) Novartis’ angiotensin receptor neprilysin inhibitor (ARNi), LCZ696, for the treatment of heart failure: LCZ696 has exhibited statistically superior data to enalapril. Expect this treatment to be introduced in the second half of 2015.

5) AbbVie’s ABT-450/ritonavir coformulated with ombitasvir (ABT-267), and dasabuvir (ABT-333) with or without ribavirin for the treatment of hepatitis C: This interferon-free, all oral regimen is supported by six Phase 3 clinical trials.

This triple combination therapy will likely be commercially launched in Q1 2015.

6) GlaxoSmithKline’s RTS,S vaccine is expected to be the first malaria vaccine

in the market. GlaxoSmithKline submitted a regulatory application to the European Medicines Agency (EMA) in July 2014; its launch is anticipated in 2015.

7) Sanofi Pasteur’s Dengue Vaccine is also expected to have a first-mover advantage, with FDA approval in 2015.

8) Ebola virus vaccines consisting of cAd3ZEBOV by GlaxoSmithKline, PSC-1001

by Newlink Genetics Corporation, and potentially an unnamed vaccine developed by Johnson & Johnson are anticipated to be entering Phase 3 trials in 2015.

In addition to new molecular entity (NME) product launches, there are abundant opportunities for generic and biosimilar drugs due to the patent expiry of several blockbuster drugs in 2014 and 2015.

Some of those include: 1) Otsuka Pharmaceutical’s Abilify (anti-psychotic).

2) Teva Pharmaceutical’s Copaxone (relapse-remitting multiple sclerosis).

3) Novartis’ Gleevec (chronic myeloid leukemia).

4) Forest Laboratories’ Namenda (Alzheimer’s disease).

5) Pfizer’s Zyvox (anti-viral) and; 6) GlaxoSmithKline’s Avodart (benign prostatic hyperplasia).

To entrench themselves in the market, technology developers could expedite the identification of biomarkers and targets for novel therapeutics. Additionally, pharma/biotech and ICT companies could enhance patient awareness of product launches.

Courtesy: Frost & Sullivan Pharma Bio World

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marketing initiative

A Robust Model for Dynamic SCM

T

oday in the pharma world, the • increasing complexity of regulatory aspects, quality expectations, and • level of testing can increase significantly the lead time. Robustness of the Supply • Chain is essential to avoid any delay for the customer, and maintain a balance to avoid excess inventory and destruction of goods.

Inventory reliability (using cycle counting rather than once a year) Occupancy rate (not more than 90%). and; OTIF (on time in full, the right item, at the right time with the right quantity). This KPI has the advantage to measure the performance of the complete logistic organization and thus, to meet the customer expectations

requirements for all industrial stages (FG, bulks), procurements (purchase order), until the launch of production (process order). This team is in charge of the planning and control of the flow through the manufacturing process.

The execution is fully supported by SAP as the information system.

Shantha SC organization has defined To reach the customer on time, Supply 4 different positions to support the Chain must plan the activity and control planning activity: the execution of every step: Supplier, The other part, the planning activity, is •The Master planner Production, Quality Control, Product fully dedicated to the flow of demand •The BOM* scheduler (linked with Release and Distribution. To address (mostly electronically). This starts suppliers) this point, Shantha has created positions with the customer demand: rolling *BOM: Bill of material, a list of all the with new responsibilities inside the forecast and customer orders. And components needed to manufacture a SC organization. then through the system, calculate product for its customers.

Following the best practices, the Shantha SC organization is divided in two parts: logistics and planning.

The logistics team is in charge of the physical flow of the goods, starting from the supply of raw material until the delivery of finished goods. This activity includes warehousing, transportation, cold chain, materials handling, and distribution.

The logistics manager needs to follow different key performance indicator (KPI): Pharma Bio World

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marketing initiative

•The Shop floor scheduler (linked with production), •QC/QA scheduler (linked with Quality Control and Quality Assurance department).

The following text will describe these key roles in the Supply Chain organization.

• The Master Planner is responsible to plan activity for the horizon 0 to 18 months (mid- term) based on the demand, and the capacity of the work center. The plan is broken down into requirements for each manufactured items by date and quantity. This plan is a key link between sales and production.

• The BOM scheduler (short and midterm): Starting from the production requirement, the scheduler is in charge of following the different steps: purchase order release, following the supplier lead time, customs clearance, the receipt of goods, and release from QC until final delivery to production. Under the vendor contract negotiated by the purchasing department, the BOM scheduler ensures that the supplier delivers on time. The performance of the supplier is followed every month with a KPI. In order to avoid stock out, the BOM scheduler must provide rolling forecast to the suppliers.

• The shop floor scheduler represents the voice of the customer in the work center and is responsible for 38 January 2015

A Robust Model.indd 38

•

creating a short term plan (0 to 3 months) and defines the priorities accordingly. Working with the production manager, a reliable and realistic schedule is created taking into account the availability of the material, human resources and equipment. The shop floor scheduler is responsible to follow the execution of the different operations.

QC/QA scheduler is based in the lab and is in charge of the short term horizon 0 to 3 months. With the QC department, this individual provides a reliable and realistic plan taking into account the testing capacity against the demand. The QC/ QA scheduler helps in prioritizing batches for testing if capacity constraints are envisioned. The QC/ QA schedule is responsible to follow the execution of the operation.

release) with a commitment spirit: it is a must to support Shantha as a reliable supplier of vaccines.

The next challenge that Shantha is working on as an international company is an optimized integration of the compliance dimension within the supply Chain processes (planning and execution), delivering products throughout the world means to deliver products at right quantity, at right time with good quality and affordable price, but also in full compliance with local registration.

Contact Benjamin Grandjean Shantha Supply Chain Support Shantha - A Sanofi Group benjamin.grandjean@sanofipasteur.com

The scheduler needs to be well trained and prepared because the activity is fast moving, and responsiveness all along the supply chain is important.

However, the scheduler must protect the work center against repeat change of plan and disturbances. Stability in the short term horizon is a key practice in maximizing capacity, and to respecting the end commitment.

Shantha is reinforcing the organization of supply Chain which has a key role of cascading the voice of customer in the plants, and coordinates transversally all industrial stages (including QC and Pharma Bio World

22-01-2015 16:19:30

press release BioAsia Healthcare Devthon to Spur Praj HiPurity Systems Launches Innovations in Life- Sciences BioWiz Smart Bioreactor BioAsia 2015 has announced the Healthcare Devthon in Hyderabad with a focus on Idea validation, Design and Rapid prototyping of Technologies and solutionsrelevant to the lifesciences & healthcare sector. The Healthcare Devthon will be organized by BioAsia with the support of HYSEA, Healthcare Innovation Cell-Ministry of Health and Family Welfare, Govt of Telangana, D-Labs incubator (ISB), Apollo Research and Innovation, Kamineni Life Sciences, Technology Business Incubator @ BITS Pilani Hyderabad and Hyderabad Hackers to facilitate the development of products and services to address the present needs of the industry. The winners of Devthon to be rewarded with seed fund grant of ` 2 lakhs.

The event will address the challenges in healthcare sector and discover solutions that can create an impact on end consumers.

The Devthon will bring in healthcare experts, data scientists, researchers, engineers on a single platform to facilitate the developments. The Devthon will emphasize on upfront validation of the ideas being built to generate relevant solutions and products.

BioAsia 2015, the 12 th edition of the Annual International Life Sciences Conference announced its partnership with the Organisation of Pharmaceutical Producers of India (OPPI) at the annual event in Hyderabad from February 2-4, 2015.

PrajHiPurity Systems (formerly Neela Systems), Praj Group Company, introduced ‘BioWiz’ Smart Bioreactor, which will help the biopharma industrymeet requirements of various bio processes in laboratory, pilot and commercial units. BioWiz Bioreactor benchmarks international standards and delivers superior operational features and advantages required in today’s global pharmaceutical industry. The ‘Smart’ aspect of this Bioreactor lies in the various innovative and smart features.

Commenting on the BioWiz Bioreactor, Gajanan Nabar CEO & MD of Praj Industries and Mihir Mehta, BU Head of PHS said, “A well-engineered process solution plays a significant role in defining efficient functioning of the production facility. High Purity industries like pharmaceuticals, biotechnology, healthcare & cosmetics are characterized by stringent demands on sterile and hygienic design and engineering. Manufacturing systems are required to meet high quality standards and guidelines set by international authorities like ISPE or ASME BPE. It is in this context that the BioWiz Smart Bioreactor has a major impact on productivity, quality and profitability of any manufacturing plant”.

Apart from BioWiz Bioreactor, PHS also introduced new models of its ‘Glacier’ Water System. ‘Glacier’ is used to generate pure, sanitized water for pharma and biotech applications. Advanced features have been added to this system like ‘one touch’ sanitization operation, complete plug and play operation, easy access for O&M with reduced footprint.

Essel Propack Conducts Corporate Jubilant Gets ANDA Nod for Re-branding Exercise MycophenolateMofetil and Rizatriptan With the advent of the New Year 2015, Essel Propack, the largest specialty packaging global company, manufacturing laminated plastic tubes catering to the FMCG and Pharma space conducted a global rollout of its brand new logo for the corporate identity with a catchphrase ‘Extraordinary Packaging’.

The new corporate logo is the first change since Essel Propack began its journey to the global markets and signifies a complete rebranding to position ‘Brand Essel’ having a strong unified Global presence.

The management has duly notified and signaled a message to all its customers, associates and employees that Essel is as dynamic as the business environment, and leaves no stone unturned to adapt itself to the changing requirements and preferences of its stakeholders.

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Jubilant Life Sciences Ltd, an integrated Pharmaceuticals and Life Sciences Company, has received Abbreviated New Drug Application (ANDA) final approval from theUS Food and Drug Administration (US FDA) for MycophenolateMofetil USP, 250 mg Capsules and 500 mg Tablets (from its US subsidiary, Jubilant Cadista Pharmaceuticals Inc) and Rizatriptan Tablets 5 mg and 10 mg (from its Indian subsidiary, Jubilant Generics Ltd).

MycophenolateMofetil USP, 250 mg Capsules and 500 mg Tablets is the generic version of Cellcept (of Roche), an immunosuppressant which is used to help prevent organ rejection in transplants.

Rizatriptan Tablets 5 mg and 10 mg is the generic version of Maxalt (of Merck), usedfor the treatment of migraine.

January 2015  39

22-01-2015 16:22:15

pharma news A u r o b i n d o P h a r m a ’s Va l s a r t a n Jubilant Appoints G P Singh as CEO Tablets Gets US FDA Approval Jubilant Life Sciences Limited (JLL), an integrated Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Valsartan Tablets USP, 40mg, 80mg, 160mg and 320mg (ANDA 202223). The product is ready for launch.

Valsartan Tablets USP, 40mg, 80mg, 160mg and 320mg are the generic equivalent to the reference listed drug product (RLD) Diovan Tablets, 40mg, 80mg, 160mg and 320mg respectively of Novartis Pharmaceuticals Corporation (Novartis) and indicated for the treatment of hypertension, to lower blood pressure. The product falls under the therapeutic category of CVS (Cardio Vascular) has a market size of approximately USD 2 Billion for the twelve months ending October 2014 according to IMS. Aurobindo now has a total of 195 ANDA approvals (170 Final approvals including 7 from Aurolife Pharma LLC and 25 Tentative approvals) from USFDA.

Cipher Acquires Melanovus Cipher Pharmaceuticals Inc has acquired the assets of Melanovus Oncology Inc, a Hershey (Pennsylvania)-based life sciences company. The assets include seven pre-clinical compounds for the treatment of melanoma and other cancers.

Founded in 2012, Melanovus acquired an exclusive global license to a library of compounds and related intellectual property from the Penn State Research Foundation. The compounds originate from work done by Dr Gavin Robertson, professor of pharmacology, pathology, dermatology and surgery at Penn State University, and director of the Penn State Hershey Melanoma Center.

Melanovus’ lead product candidate, Nanolipolee-007, is a liposomal formulation of a plant-derived compound that is a firstin-class cholesterol-transport inhibitor which has demonstrated anti-proliferative activity against certain melanoma cell lines (including B-raf resistant strains) in vitro as well as in early in vivo mouse studies. Cipher will pursue pre-clinical studies leading to Investigational New Drug status with the US Food and Drug Administration, Health Canada and other health authorities.

The plan for the development of the remaining compounds in the portfolio has not yet been established.

The transaction includes an upfront payment to Melanovus of USD 500,000, as well as the payment of certain IP expenses related to patent prosecution and maintenance.

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Pharmaceuticals and Life Sciences Company announced that Gurpartap Singh Sachdeva (G P Singh) has been appointed as CEO of Jubilant Pharma Ltd, a 100 per cent wholly-owned subsidiary of JLL. Singh will have overall responsibility for the operations under Jubilant Pharma and will report to the Jubilant Pharma Board. He will be based in the United States.

Prior to Jubilant, Singh had served as President of Sun Pharmaceuticals, USA and contributed to the growth of Sun’s US business. He has worked extensively both in India and in the US in various leadership roles pertaining to Strategy, M&A, Commercial and Operations.

Perrigo Launches Generic Clobex Spray Perrigo Company plc has launched clobetasol propionate spray, 0.05%, the generic equivalent to Clobex Spray, 0.05%. Perrigo was the first generic filer against this product and it is entitled to 180 days of generic exclusivity. The launch date was agreed upon in a litigation settlement between Perrigo and Galderma Laboratories, LP. Clobetasol propionate spray, 0.05% is indicated for the topical treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area in adults 18 years of age or older and 52week sales of the product were approximately USD 100 million, according to IMS Health.

Isis, Alnylam Extend Partnership for RNA Therapeutics Isis Pharmaceuticals, Inc and Alnylam leaders in RNA-targeted therapeutics agreement, extending their existing – formed originally in 2004 – to lead commercialization of RNA therapeutics.

Pharmaceuticals, Inc, have formed a new strategic partnership the development and

This new agreement includes a cross-license of intellectual property (IP) on four disease targets, providing each company with exclusive RNA therapeutic license rights for two programs.

The agreement also includes a non-exclusive technology IP cross-license, providing each company rights to certain of each other’s technology advances for RNA therapeutics through April 2019.

Pharma Bio World

22-01-2015 16:23:44

pharma news Shire to Acquire NPS Pharma

Supernus Sues Par for Patent Breach

Shire plc and NPS Pharmaceuticals, Inc have entered into a merger agreement pursuant to which Shire will acquire all the outstanding shares of NPS Pharma for USD 46.00 per share in cash, for a total consideration of approximately USD 5.2 billion.

Supernus Pharmaceuticals, Inc has sued generic drug makers Par Pharmaceutical Companies, Inc and Par Pharmaceutical, Inc (collectively “Par”) for infringement of four patents covering its antiepileptic drug Trokendi XR. Supernus’ United States Patents Nos. 8,298,576, 8,298,580, 8,663,683 and 8,877,248 cover once-a-day topiramate formulations and methods of treating seizures using those formulations. Patent protection for Trokendi XR expires no earlier than 2027.

Shire will accelerate the growth of NPS Pharma’s innovative portfolio through its market expertise in gastrointestinal (GI) disorders, core capabilities in rare disease patient management, and global footprint. The transaction has been approved unanimously by the Boards of Directors of both Shire and NPS Pharma.

NPS Pharma is a rare disease-focused biopharmaceutical company and its first product, Gattex/Revestive (teduglutide [rDNA origin]) for injection, is approved in the United States and Europe1 to treat adults with short bowel syndrome (SBS) who are dependent on parenteral support. NPS Pharma also has a registration phase product, Natpara/Natpar (rhPTH -83) for the treatment of hypoparathyroidism (HPT).

The Complaint—filed in the US District Court for the District of New Jersey—alleges that Par infringed Supernus’ Trokendi XR patents by submitting to the Food and Drug Administration (FDA) an Abbreviated New Drug Application (ANDA) seeking to market a generic version of Trokendi XR prior to the expiration of Supernus’ patents. Filing its Complaint within 45 days of receiving Par’s Paragraph IV certification notice entitles Supernus to an automatic stay preventing the FDA from approving Par’s ANDA for 30 months.

Aegerion Buys Myalept US FDA Okays Impax’s Rytary Impax Pharmaceuticals, a division ofImpax Laboratories, Inc, has announced that the US Food and Drug Administration (FDA) approved Rytary, an extended-release oral capsule formulation of carbidopa-levodopa, for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication and / or manganese intoxication. Rytary is not for use in patients using nonselective monoamine oxidase inhibitors (MAO) inhibitors.

Rytary contains immediate release and extended-release beads, with a specific amount of carbidopa and levodopa in a 1:4 ratio, and provides both initial and extended levodopa plasma concentrations after a single dose. Rytary may be swallowed whole or, for patients who have trouble swallowing, the capsule may be opened and the beads sprinkled on applesauce and consumed immediately.

The Rytary clinical program studied patients with early (levodopanaive) to advanced Parkinson’s disease in the US and in Europe.

In APEX-PD (Study 1), a trial that enrolled and randomized 381 levodopa-naive patients, the study met its primary efficacy endpoint of mean change from baseline in the sum of Unified Parkinson’s Disease Rating Scale (UPDRS) Part II (activities of daily living) score and UPDRS Part III (motor skills) score for Rytary versus placebo at Week 30 (or early termination).

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Aegerion Pharmaceuticals, Inc has completed the acquisition of Myalept (metreleptin) for injection, an orphan drug product that is indicated to treat complications of leptin deficiency in patients with generalized lipodystrophy (GLD). Execution of the asset purchase agreement setting forth the terms of the acquisition was announced on November 6, 2014. Aegerion paid USD 325 million upfront to acquire the global rights to develop, manufacture and commercialize Myalept, subject to an existing distributor license with Shionogi covering Japan, South Korea and Taiwan.

Myalept is approved in the United States for the treatment of GLD, and it has orphan drug designation in the United States, European Union and Japan.

Mylan Launches Generic Epivir-HBV Mylan Inc has announced the US launch of its Lamivudine Tablets, 100 mg, which is the generic version of GlaxoSmithKline’s EpivirHBV. Mylan received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the treatment of chronic hepatitis B virus infection associated with evidence of hepatitis B viral replication and active liver inflammation.

Lamivudine Tablets, 100 mg, had US sales of approximately USD 18.1 million for the 12 months ending September 30, 2014, according to IMS Health.

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pharma news Oramed’s ORMD-0901 Receives Newron Starts Phase II Study of sNN0029 Israel Patent Oramed Pharmaceuticals Inc, a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, has announced that the Israel Patent Office has granted the Company’s patent for its invention, titled “Methods and Compositions for Oral Administrations of Exenatide.”

Glucagon-like peptide-1 (GLP-1) is an incretin hormone that stimulates the secretion of insulin from the pancreas. Exenatide, a GLP-1 analog, is currently marketed in injectable form only, and is indicated for treatment of type 2 diabetes. Exenatide induces insulin release at increased glucose levels and causes a feeling of satiety, which results in reduced food intake and weight loss. Oramed’s oral GLP-1 capsule based on the company’s PODTM technology could significantly increase compliance and become a valuable tool in the treatment of diabetes.

Oramed Pharmaceuticals is a technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection.

Addex, DMRF to Explore Use of Dipraglurant in Dystonia Treatment Addex Therapeutics, a leading company pioneering allosteric modulation-based drug discovery and development and the Dystonia Medical Research Foundation (DMRF) has announced entering a collaboration to explore the use of dipraglurant to treat dystonia, the third most common movement disorder following essential tremor and Parkinson’s disease. Dipraglurant, a novel small molecule inhibitor of the metabotropic glutamate receptor 5, has shown promise in the treatment of levodopa-induced dyskinesia and dystonia in Parkinson’s disease.

Dipraglurant has also been shown to normalize the effects of the TOR1A/DYT1 dystonia mutation in the brains of mice. The objective of the collaboration is to design a detailed development plan and regulatory path as well as identifying key option leaders and patients for a Phase 2 clinical trial. In addition, Addex recently reported on 9 January, plans to start clinical testing of the therapeutic effect of dipraglurant in patients with cervical dystonia in collaboration with Professor Dirk Dressler of The Hannover Medical School.

“The DMRF and Addex each embody spheres of expertise that complement the other very well,” said DMRF President Art Kessler, who was diagnosed with dystonia as a child. “This drug represents an important opportunity for the dystonia community to examine a potential new treatment option in collaboration with established experts in drug discovery and development.”

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Newron Pharmaceuticals has announced the initiation of a Phase II study of its novel molecule sNN0029 in patients with Amyotrophic Lateral Sclerosis (ALS). This safety and preliminary evidence of efficacy Phase II trial of sNN0029 is supported by funding from the Wellcome Trust. sNN0029 is a recombinant human vascular endothelial growth factor (rhVEGF-165) that is administered intracerebroventricularly (ICV). Administration of sNN0029 in animal models of ALS increased survival of motor neurons that degenerate and are a leading cause of the disability and symptoms in patients with ALS. Animals with the G93A-SOD1 mutation, known to be associated with ALS in humans, who receive rhVEGF-165 survive longer and show improved muscular strength compared to controls. Based on its mechanism of action, ie, direct and indirect effects preventing death of motor neurons, sNN0029 may represent a unique treatment opportunity for patients with ALS.

Dr Reddy’s Closes Habitrol Acquisition Dr Reddy’s Laboratories has announced that it has closed the acquisition of Habitrol brand (an over-the-counter nicotine replacement therapy transdermal patch) from Novartis Consumer Health Inc. following issuance of the proposed consent order from the US Federal Trade Commission (FTC) on November 26, 2014. The company had earlier entered into an asset purchase agreement with Novartis Consumer Health Inc. to acquire the title and rights of Habitrol brand and to market the product in the US market. With this closure, the company has assumed responsibility for the product and will commence shipments of the product in the market shortly.

Alexion Completes Rolling BLA Submission to US FDA Alexion Pharmaceuticals, Inc has announced completion of the rolling submission of a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for asfotase alfa, an investigational, first-in-class enzyme replacement therapy for the treatment of hypophosphatasia (HPP). HPP is a genetic, chronic and progressive ultra-rare metabolic disease that can lead to destruction and deformity of bones, profound muscle weakness, seizures, respiratory failure and premature death.The BLA submission includes data from 71 treated patients with HPP enrolled in three prospective studies and their extensions, as well as a retrospective natural history study in infants with HPP and a separate retrospective natural history study in juveniles with HPP. Pharma Bio World

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biotech news TxCell Collaborate with Ferring for Biogen Acquires Convergence Treatment of IBD Biogen Idec has agreed to acquire UK-based TxCell SA, a biotechnology company developing innovative, cost-effective, personalized T cell immunotherapies using antigen specific regulatory T-cells (Ag-Tregs) for severe chronic inflammatory and autoimmune diseases, has announced a further enhancement to the development of its lead product Ovasave for the treatment of Inflammatory Bowel Diseases (IBD), including Crohn’s disease and ulcerative colitis. The collaboration, option, development and license agreement between TxCell and Ferring International Center SA has been assigned to Trizell Holding SA, an affiliate member of the Dr Frederik Paulsen Foundation.

Trizell was established by the Dr Frederik Paulsen Foundation to provide specialist management and scientific and development expertise that is dedicated to advanced cellular and gene therapies. This new class of highly promising biological therapies includes TxCell’s Ovasave. Ferring executed an exclusive worldwide agreement in December 2013 with TxCell, securing the option to be the commercializing entity for Ovasave for the treatment of IBD, including Crohn’s disease and ulcerative colitis.

Convergence Pharmaceuticals, a clinical-stage biopharmaceutical company with an innovative portfolio of ion channel-modulating product candidates for neuropathic pain. Biogen Idec plans to leverage Convergence’s expertise in chronic pain research and clinical development to accelerate the growth of its pain portfolio.

The acquisition is centered on the development of Convergence’s Phase 2 clinical candidate (CNV1014802), which has demonstrated clinical activity in proof of concept studies for trigeminal neuralgia (TGN), a chronic orphan disease consisting of debilitating, episodic facial pain. CNV1014802 is a novel small molecule state-dependent sodium channel blocker that preferentially inhibits Nav 1.7 ion channels. The Nav 1.7 ion channel is a genetically validated target for pain in humans.

Additionally, CNV1014802 has demonstrated proof of concept for treating pain associated with lumbosacral radiculopathy, more commonly known as sciatica, and has potential applicability in several other neuropathic pain states.

Advaxis, GOG Foundation Join Hands for MedImmune, Omnis Ink Oncolytic Phase III Trial of ADXS-HPV Immunotherapy Deal Advaxis, Inc, a clinical-stage biotechnology company MedImmune, global biologics research and development arm of AstraZeneca, has entered into a licensing agreement with Omnis Pharmaceuticals (Omnis), a privately-held biotechnology company focused on the development of oncolytic viruses.

This agreement will allow MedImmune to combine key agents from its investigational immunotherapy portfolio with Omnis’ lead investigational oncolytic virus programme, a genetically engineered strain of vesicular stomatitis virus (VSV). The programme is currently being studied in a Phase I clinical trial as a monotherapy for the treatment of hepatocellular carcinoma and other cancers that have metastasised to the liver.

Oncolytic viruses are designed to target tumour cells with the killing potency of viruses. VSV is among a group of naturally occurring viruses that can be engineered to selectively infect tumour cells and destroy them without harming healthy cells.

These oncolytic viruses represent a potentially powerful new tool in the fight against cancer and may be synergistic with various immunotherapies currently being developed by MedImmune.

Under the terms of the agreement, MedImmune has the license to develop and, if successful, to commercialise Omnis’s lead oncolytic virus programme.

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developing cancer immunotherapies is entering into a clinical trial collaboration agreement with the GOG Foundation, Inc, to evaluate the safety and efficacy of Advaxis’s lead cancer immunotherapy, ADXS-HPV, in a global Phase 3 cervical cancer trial. ADXS-HPV is an investigational Lm-LLO immunotherapy bioengineered to generate an immune response to the HPVassociated tumor specific oncogene.

Under the proposed collaboration, the GOG and Advaxis will conduct an adequate and well-controlled Phase 3 clinical trial of concurrent chemotherapy and radiation therapy (CCRT) compared to CCRT combined with ADXS-HPV in women diagnosed with high-risk, locally advanced cervical cancer. Prior to commencing this study, Advaxis will discuss the proposed Phase 3 program with the US FDA and will update its investigational new drug submission.

Advaxis also plans to request a Special Protocol Assessment (SPA) from the FDA prior to commencing this collaborative study.

A SPA is a declaration from the FDA that a Phase 3 trial’s design, clinical endpoints, and statistical analyses are supportive for FDA approval; however, the FDA makes final approval determinations following a complete review of data in a marketing application.

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biotech news CytRx Posts Positive Interim Result from J&J Gets USD 115 Million for Ebola Phase 2 Aldoxorubicin Trial Vaccine Development CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, has announced positive interim results from its ongoing Phase 2 clinical trial evaluating the safety and efficacy of aldoxorubicin for the treatment of Kaposi’s Sarcoma (KS) in HIV-infected patients.

The clinical results reported are from 9 patients, 6 of which carried the worst KS prognosis. Also, 4 of the 9 patients had received from 1 to 8 prior liposomal doxorubicin (Doxil) cycles.

Efficacy results revealed that all 9 patients exhibited a decrease in skin lesions and in the number of cancer cells expressing the KS virus DNA. Of the six patients with lung tumors, four patients (66 per cent) demonstrated either a partial or complete response, with no patients demonstrating progression. Data thus far show that aldoxorubicin can be detected in all tumor biopsies 24 hours following drug administration. Preliminary safety results showed only two patients (22 per cent) experienced a grade 4 adverse event (transient neutropenia and anemia). Other adverse events were mild and most were unrelated to aldoxorubicin.

Boehringer Ingelheim and Sanofi Ally to Produce Biopharmaceuticals Boehringer Ingelheim and Sanofi have announced that they enter into an alliance to extend Sanofi’s manufacturing capacity network for therapeutic monoclonal antibodies. Boehringer Ingelheim’s cell culture operations will provide contract manufacturing capacities to support the production of Sanofi’s biologics pipeline. Under the terms of the agreement Sanofi will have access to Boehringer Ingelheim’s capabilities to transfer and manufacture therapeutic monoclonal antibodies for global market supply. Initial product transfers will begin in early 2015.

Roche Acquires Trophos Roche has agreed to acquire Trophos, a privately held biotechnology company based in Marseille, France. Trophos’s proprietary screening platform generated olesoxime (TRO19622), which is being developed for SMA – a rare and debilitating genetic neuromuscular disease that is most commonly diagnosed in children. Results from a pivotal phase II clinical trial with olesoxime in SMA showed a beneficial effect on the maintenance of neuromuscular function in individuals with Type II and non-ambulatory Type III SMA, as well as a reduction in medical complications associated with the disease.

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Johnson & Johnson’s (J&J) newly formed groups supporting work on its experimental Ebola vaccine to receive EUR 100 million (USD 115 million) from Europe’s Innovative Medicines Initiative to accelerate development.

Earlier this month, J&J had started clinical trials of its two-injection vaccine, which uses a booster from Denmark’s Bavarian Nordic, making it the third such product to enter human testing. A total of 2 million regimens of the prime-boost vaccine will be available through the course of 2015, with the ability to quickly scale up to 5 million regimens, if required, over a 12- to 18-month period.

This increased projection is an update to Janssen’s previous goal of producing more than 1 million regimens by the end of 2015, with 250,000 regimens for broad application in clinical trials by May 2015.

The new initiative will see J&J join with institutions including the London School of Hygiene & Tropical Medicine, the University of Oxford and the Institut National de la Sante et de la Recherche Medicale to form consortia working on different aspects of vaccine development.

Europe’s Innovative Medicines Initiative (IMI) is a public-private scheme jointly paid for by the European Commission and the pharmaceuticals industry. The IMI said in November it would invest 280 million euros in Ebola research, with the lion’s share going to vaccines.

Two other experimental vaccines, one from GlaxoSmithKline and a rival from NewLink and Merck, are already in clinical development.

Horizon Buys Haplogen Genomics Horizon Discovery Group plc, the international life science company supplying research tools and services to organizations engaged in genomics research and the development of personalized medicines, has agreed to acquire Haplogen Genomics GmbH, a biotechnology company based in Vienna, Austria, for an initial consideration of 6.0 million pound (approximately EUR 7.7million) in cash and the issue of new ordinary shares with further potential earn-out payments based on future performance to be satisfied by the issue of new ordinary shares having an aggregate value of up to approximately 3.9 million pound (EUR 5.0 million).

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biotech news Neurocrine’s NBI-77860 Gets Orphan J&J Gets USD 115 Million for Ebola Drug Status Vaccine Development Neurocrine Biosciences, a biopharmaceutical company focused on research and development, has announced that NBI-77860, a proprietary corticotropin releasing factor 1 (CRF) receptor antagonist, has been granted orphan drug status by the United States Food and Drug Administration (FDA) for the treatment of congenital adrenal hyperplasia (CAH) a disease that affects approximately 20,000-30,000 people in the United States.

NBI-77860 is a potent, selective non-peptide CRF receptor antagonist as demonstrated in a range of in vitro/in vivo assays and human clinical studies. Blockade of CRF receptors at the pituitary has been shown to decrease the release of ACTH, which in turn decreases the production of adrenal steroids including androgens, and potentially the symptoms associated with classic CAH. Lower ACTH levels would also reduce the amount of exogenous corticosteroid necessary for classic CAH patients to thrive avoiding the side-effects currently associated with excessive steroid therapy.

Provectus to Meet US FDA to Review Operational Aspects of PV-10 Trial Provectus Biopharmaceuticals Inc, a development-stage oncology and dermatology biopharmaceutical company, has announced today that it will be meeting with the US Food and Drug Administration to review certain operational aspects of the protocol for its planned phase 3 clinical trial of intralesional PV-10, its novel investigational drug for cancer, as a treatment for melanoma. No date for this meeting has been agreed upon as yet.

Eric Wachter, PhD, CTO of Provectus, stated, “When we submitted the protocol to the Agency in November, we included a brief list of questions about certain operational aspects of the protocol, in particular regarding eligibility requirements relevant to maximizing the speed of enrollment of patients in the study. This is standard practice for a pivotal submission. The FDA has subsequently indicated that a formal meeting is appropriate to assure that these questions are addressed in a timely and documented manner. We hope the meeting will occur in January or early February 2015. We currently have eight sites, four in the U.S. and four in Australia, in our expanded access program that are using PV-10 for melanoma and other cutaneous malignancies. They will provide a path to quickly starting enrollment once this review period is finished.

In addition, we expect additional sites to join the study pending action by their respective Institutional Review Boards.”

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Alimera Sciences, Inc, a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals announced that the first unit of ILUVIEN has been sold in Portugal for the treatment of vision impairment associated with chronic diabetic macular edema insufficiently responsive to available treatments. Portugal is the third country in which ILUVIEN is now commercially available. The National Authority of Medicines and Health Products of Portugal (Autoridade Nacional do Medicamento e Produtos de Saude, Infarmed) granted marketing authorization to ILUVIEN, following the completion of the Decentralized Regulatory Procedure (DCP) in the European Union (EU).

Epirus Launches Remicade Biosimilar in India Epirus Biopharmaceuticals Inc, a Boston-based biopharmaceutical company focused on the global development and commercialization of biosimilar monoclonal antibodies, has announced the launch of its first product, Infimab (BOW015), the first infliximab biosimilar in India. Infimab, a Remicade (infliximab) biosimilar, is being launched in cooperation with Epirus’ commercialization partner Ranbaxy Laboratories Limited. Infimab will be manufactured by Reliance Life Sciences at a facility in Mumbai. Remicade is currently marketed globally for the treatment of inflammatory diseases including rheumatoid arthritis, Crohn’s Disease, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis and psoriasis.

MHRA Validates RedHill’s MAA for BEKINDA RedHill Biopharma Ltd, an Israeli biopharmaceutical company primarily focused on late clinical-stage drugs for inflammatory and gastrointestinal diseases, including gastrointestinal cancers, announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has validated the Marketing Authorization Application (MAA) for BEKINDA (RHB-102), a proprietary, extended-release, once-daily oral pill formulation of the antiemetic drug ondansetron indicated for the prevention of chemotherapy and radiotherapy-induced nausea and vomiting (CINV and RINV, respectively), and initiated the formal review process for the application3. RedHill expects to receive feedback from the MHRA during the second half of 2015.

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Next-generation Capping Heads With the ROBA-capping head, the hysteresis technology not only provides contactless and therefore wear-free torque transmissions: It is also impact-free and low-vibration, and thus guarantees a longer plant lifetime. The capping heads also feature a high torque repetitive accuracy of +/2%. With their continuous and impact-free closing torque, they are therefore the optimum choice for the application of plastic screw caps with preformed threads. They are better suited for the task than permanent magnet couplings with intermittent torque in slip operation, which in part “hammer down” the screw caps and make them hard to open. With the ROBA-capping head, the limit torque can be easily and continuously adjusted, and can be read off directly via a scale. The enclosed construction also makes the capping heads resistant to dirt and aggressive media. It is possible to adapt the head pressure easily according to the customer requirements.

iSense Software for the ISM Technology Mettler Toledo offers a new version of its iSense software for the Intelligent Sensor Management (ISM) technology with valuable features. Mettler Toledo’s digital sensor technology ISM, has transformed the way analytical sensors are handled and maintained from first installation to end of life. ISM offers a level of performance and convenience that is not available with other systems. iSense, the accompanying software for ISM, streamlines all sensor activities. It provides valuable features such as sensor calibration away from the process, electronic documentation, instant evaluation of a sensor’s health, and predictive information on when maintenance will be required.

The latest version of iSense enables seamless management of ISM sensors and delivers exceptional usability. ISM and iSense have been designed to be adaptable to your current needs and your future ones. Planned developments, such as a mobile app that provides a quick sensor check on the go, mean that ISM will remain at the forefront of analytical measurement technologies.

For more information, please contact:

For more information, please contact:

Chr. Mayr GmbH + Co KG Eichenstraße 1 87665 Mauerstetten, Germany Tel: +49 8341 / 804-232 | Fax: +49 8341 / 804-49232 E-mail: hermann.bestle@mayr.de

Mettler-Toledo Ingold Inc 900 Middlesex Turnpike, Building 8 Billerica, MA 01821, U.S.A. Tel: +1 800 352 8763 | Fax: +1 888 687 7687 E-mail: santare.rukaite@mt.com

BHR Type Dryer Wet air at pressure of 5.5-8.0 kg/cm² (g) and at 50ºC temperature enters the pre-filter. Here all the mist particles are entrained and collected in the bowl of the filter. This moisture is discharged from the bottom plug regularly. An automatic condensate discharge device is provided. From the prefilter air passes through the inlet 4-way valve to the drying tower.

The air passes upwards and in turn gets dried by the charge of silica gel/activated alumina/molecular sieves packed in the tower. After coming out of the tower, the air passes through the second 4-way valve. Then the air passes through the after filter which removes the dust particles, etc, and the air coming out of this is pure and dry air can be fed to the application of work area. Each tower remains on line for drying up to 6 hours.

After every 6 hours the towers change over automatically through a motorised cam timer. After changeover the saturated tower will be regenerated.

For more information, please contact: Mellcon Engineers Pvt Ltd B-297 Okhla Indl Area, Phase I New Delhi 110 020 Tel: 011-26811727, 26816103 | Fax: 91-011-26816573 E-mail: mellcon@mellcon.com

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Imaging Accessory Malvern Instruments offers two new additions to the Mastersizer portfolio. Hydro Sight is a state-of-the-art imaging accessory that makes it quicker and easier to develop and apply the robust particle sizing methods that are essential across industry. The Hydro SV, a new wet dispersion unit for the Mastersizer 3000, answers the need for reliable particle size data when material is scarce.

Hydro Sight provides real-time visual monitoring of the dispersion process that precedes every laser diffraction particle size measurement. Dispersion is essential to ensure that particles are measured in a representative, relevant state. The images that Hydro Sight delivers make it quicker to identify optimal dispersion conditions for wet or liquid particle size analysis methods. Furthermore, they allow the user to literally see what has gone wrong if problems are encountered during method application or transfer. The outcome is more efficient, less expensive analysis across the lifetime of a product.

Hydro Sight uses lens-less technology (patent pending) to measure basic morphological data including particle size and elongation distribution, across a wide particle size range. A unique ‘dispersion index’ quantifies the state of dispersion of any given sample. An advanced anomaly detection feature is also provided to record images of any outlying particles that are particularly unusual in terms of size or shape. These images help users to identify and rationalize the root cause of any outof-specification results.

For more information, please contact: Malvern Aimil Instruments Pvt Ltd Naimex House, BSEL Tech Park B Wing – 906 Sector 30A, Opp: Vashi Railway Station, Vashi, Navi Mumbai 400 705 Tel: 022-39183596 | Fax: 92-022-39183562 E-mail: Stuart.Wakefield@malvern.com

Professional pH Electrode Hanna Instruments offers HALO, the world’s first professional pH probe with Bluetooth Smart (Bluetooth 4.0) technology. With its wireless design and unique rhythmic, blue indicator light, HALO is changing the way pH is measured. HALO is a high quality, double junction, refillable glass pH probe with a builtin temperature sensor that can be used virtually anywhere: in the field, laboratory or classroom. Using Bluetooth Smart technology, HALO transmits measurement data directly to an iPad (3 rd generation or newer) running the Hanna Lab App. This combination frees the HALO from cumbersome wires and the need for expensive meters, taking advantage of the widespread usage and versatility of the Apple iPad. The Hanna Lab App is a free application that turns the iPad into a full-featured pH meter when used with the Hanna HALO pH electrode. Functions include calibration, measurement, continuous data logging, graphing and data sharing. Measurement and logging of pH and temperature at one second intervals start as soon as the probe is connected. Measurements can be displayed with tabulated data or as a graph. The graph can be panned and zoomed with the iPad’s pinch-to-zoom technology for enhanced viewing.

For more information, please contact: Hanna Equipments (India) Pvt Ltd Aum Sai Bldg, 3/4/5/6, 1 st Floor Plot No: 23-C, Sector 7, Kharghar, Navi Mumbai 410 210 Tel: 022 27746554, 27746555, 27746556 E-mail: marketing@hanna-india.com

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Centrifugal Air Blowers Vacunair Engg Co Pvt Ltd offers centrifugal air blowers in capacity up to 75,000 m 3/hr and pressure up to 1,500 mm WG. This energy savings with fans utilises variable inlet vanes; high pressure atomisation/combustion air as per specific requirement to suit burners; highly efficient design impeller fabricated in aluminium/MS riveted high strength construction fitted with hub; minimum overhung and weight design for low starting inertia; impeller dynamically balanced; different drive for direct coupled/directly mounted on motor shaft/vee belt; etc. Optional accessories like inlet/outlet silencer, air filter, air control devices can be supplied. Other application includes cooling, conveying, air knives, fluidizing system, glass blowing, drying and various process system.

Portable Leak Detector CS Instruments GmbH, Germany, offers LD400 portable leak detector with 2â&#x20AC;? display and ultrahigh sensitivity that reduces the expenses of compressed air systems and eliminate leakages. It is long lasting device which transforms characteristic ultrasonic signals into audible sound from distance of several meters. Sound-proof headset enables to detect leak in extremely noisy environments. LD400 has internal battery for power supply of up to 16 hours. Leakages can be detected in compressed air lines, gas, vapour and vacuum plants, refrigerating plants and door seals.

For more information, please contact:

For more information, please contact:

Vacunair Engg Co Pvt Ltd

AV Measurement & Control (India) Plot No: P46/1, 102 Sonata Comml Complex Nr ICICI Bank, MIDC, Dombivli (E), Maharashtra 421 203 Tel: 0251-2424418, 6458885 E-mail: vadnerkar@avmacindi8a.com / sheeja@avmacindia.com

Nr Gujarat Bottling, Rakhial Ahmedabad, Gujarat 380 023 Tel: 079-22910771, 22910772 | Fax: 91-079-22910770 E-mail: info@vacuunair.com

Supertor Supertor is a pump like machine to handle slurries and liquids. It can grind, mix and pump in one operation. It is developed from a centrifugal pump with an inclined disc which is at an angle to the shaft instead of a normal impeller. This creates strong turbulence which causes the acceleration of the medium in both axial and radial direction, resulting in pumping and intense mixing of the medium. Notched teeth in the rotor disc mesh with teeth of stator to effect disintegration or crushing. There is just a gap of 0.5 mm between stator and rotor. The multiple movements cause thrust and shear stress, and can create intensive mixing and conveyance depending on properties of material. A unique feature is the ability to reduce particle size to controlled sizes with standard distribution across the medium. With the Supertor a variety of processes can be performed pumping, homogenization, emulsification, disintegration, increasing rate of reaction by intense mixing, impurities dissolution during cake washing, rapid dissolution of difficult to dissolve solids, extraction, reduction of agglomerates, grinding, deflaking, crushing, shredding, mixing, etc.Two models are available, viz, size 22, size 25 with stuffing box or mechanical seal design. It is a high shear machine. Both head and flow rates depends upon fluid being handled, its density, viscosity, solid content, etc. Typically size 22 Supertor can give flow of 5-7 m 3/hr. and size 25 more than 7 m 3/hr. ndustries served are pigment, dyestuff, pharma, detergent, spices, rubber, adhesive, silica, paper and pulp, etc.

For more information, please contact: Dalal Engineering Pvt Ltd Kavesar Village, Nr Suraj Water Park Thane-Ghodbunder Road, Thane (W), Thane, Maharashtra 400 615 Tel: 022- 25976201, 25976202, 25976205 E-mail: sales@dalalengineering.com

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Electro-deionization PrajHiPurity Systems (formerly Neela Systems), Praj Group Co, offers new models of its ‘Glacier’ Water System used to generate pure, sanitized water for pharma and biotech applications. Advanced features have been added to this system like ‘one touch’ sanitization operation, complete plug and play operation, easy access for O&M with reduced footprint. It can be remotely monitored on request. Glacier is a fully standardized and automated RO+EDI combination. It is a skid-based system for generation of purified water. Glacier takes complexity out of purification. It can be configured to specific requirements for purification of thousands of litres of water without any operator intervention. The Glacier can be made in varied capacities ranging from 500 to 5,000 LPH in convenient steps. This timetested purification module consistently delivers purified water as per USP and EU Standards. It has built-in variants to suit automation levels as required.

BioWiz Smart Bioreactor PrajHiPurity Systems offers ‘BioWiz’ Smart Bioreactor / Fermenters, which will help the biopharma industry meet requirements of various bio-processes in laboratory, pilot and commercial scales. The ‘Smart’ aspect of this Bioreactor lies in the various innovative and smart features. The team of bioprocess engineers who were actually handling various processes (end-users) have designed BioWiz Bioreactors / Fermenters to make it more user-friendly.

This BioWiz Smart Bioreactor is cost-effective in design that meet the exact requirements of the pharma industry; designed as per International Standards to meet regulatory, process as well as end-user requirements; fully automatic process sequence operations; Golden Batch concept for real time comparison of process parameters; advance automation – PLC-SCADA based system; in-built safety parameters and is web-based remotely monitored. Other advanced features include complete plug and play operation, easy access for O&M with reduced footprint and documentation meeting the regulatory requirements.

For more information, please contact:

For more information, please contact:

Praj HiPurity Systems Ltd, (formerly Neela Systems Ltd) Solitaire Corporate Park, Unit No: 1211, 1 st Floor C S No: 131A-1/A, Andheri (E), Mumbai 400 093 Tel: 022-40888444, 40888372 | Fax: 91-022-28747129 E-mail: info@prajhipurity.net

Praj HiPurity Systems Ltd, (formerly Neela Systems Ltd) Solitaire Corporate Park, Unit No: 1211, 1 st Floor C S No: 131A-1/A, Andheri (E), Mumbai 400 093 Tel: 022-40888444, 40888372 | Fax: 91-022-28747129 E-mail: info@prajhipurity.net

Catalogue for the Scientific and Process Industries Cole-Parmer released its 8 th annual catalogue for the scientific and process industries. The company has also released its 3 rd annual catalogue dedicated to the food and beverage industry. The new 2014/15 India catalogue has numerous unique and new products, as well as returning favourites. It offers a full selection of products and services to enhance efficiency and produce best practices. Users can select from highly efficient laboratory essentials, lab equipment, fluid handling, and process equipment and find exactly what they need for their application from research and development to pilot plants to scale-up. The catalogue also has convenient dual pricing featuring custom duty exempt prices and prices in rupees, making it handy for users to set up supply contracts.The catalog includes a wide portfolio of products to address customers’ demanding manufacturing and process application needs. It features the recently introduced Masterflex pumps with anti-drip functionality, the Digi-Sense line of precision measurement Instruments, Cole-Parmer mixers and stirrers, analytical instruments for the food and feed line, lab filtration, cold storage solutions, new safety consumables and much more.

For more information, please contact: Cole-Parmer India Pvt Ltd 403-404, Delphi - B, Hiranandani Business Park Powai, Mumbai 400 076 Tel: 022-67162253, 67162222, 67162229 E-mail: response@coleparmer.in / info@coleparmer.in

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events diary

BioAsia 2015

8 th Pharmacovigilance 2015

Date: 2 nd – 4 th February 2015

Date: 24 th – 25 th February 2015

Venue: Novotel Hyderabad Convention Centre, Hyderabad, Telangana

Venue: Marriott Marble Arch Hotel, London, UK

BioAsia 2015 - the twelfth edition of the widely attended annual convention, is all set to bring together the global industry leaders, researchers, policy makers, innovators, and investors together on one platform discussing the new opportunities in the transition.

BioAsia 2015, as a unique meeting platform of leaders from across the industry, will offer the right opportunities to catch the right notes and develop strategies to succeed in emerging markets like India.

Contact: Paridhi Gupta Tel: +91 40 6644 6477 / 6577 E-mail: paridhi@bioasia.in Website: www.bioasia.in

Pharma Commercial and SFE Summit, MENA Date: 2 nd – 4 th February 2015 Venue: Dubai, United Arab Emirates The Pharma Commercial and SFE Summit, MENA is a platform for industry leaders to discuss how to adopt global strategies, to drive up sales efficiency through improved training and continue the evolution of closed loop marketing in the MENA region. This three day forum provides valuable insights into the MENA pharmaceutical market and reveals the latest models of sales techniques, examines the best ways to implement effective commercial strategies, teaches how to customize the sales tactics into local conditions, new innovations in Closed Loop Marketing, Key Account Management, the need to become more patient centric, provides a comparison of sales activities in MENA region versus global markets and discusses all the most pressing topics that are currently being faced.

Contact: Ciaran Chapman Tel: +421 221 025 322 | Fax: +421 252 444 220 E-mail: enquiry@lloydsconferences.com Website: www.pharmasfedubai.com 50 January 2015

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8th Annual Pharmacovigilance 2015 will bring together top pharmaceutical, biotechnology and regulatory representatives under one roof that will address the key issues of the industry.

The entire program will cover the detection, analysis and prevention of adverse drug reactions. It will be studied with the help of case studies and industry experiences. This conference will help the drug safety representatives from the pharmaceutical industry and academic and quality research organisations who wish to understand how to avoid common deficiencies in inspections by learning from the experiences of others; to gain a greater understanding of new and existing pharmacovigilance requirements, and to improve their organisations’ compliance with pharmacovigilance requirements.

Contact: Deepak Raj Tel: +91 9171350244 E-mail: Deepakrajvirtueinsight@gmail.com Deepak@virtueinsight.co.in

Anti-Counterfeiting Pharma 2015 Date: 11th – 12 th March Venue: Marriott Regents Park, London, UK According to a report by Allied Market Research ‘the global anticounterfeit packaging market in food and pharmaceuticals is forecast to attain market value of USD 142.7 billion by 2020 from USD 57.4 billion in 2013, growing at 13.9 per cent CAGR during 2013 to 2020. Anti-Counterfeiting Pharmaceutical Conference will bring experts from cross-sector organisations together to share their knowledge and experience on the the key issues and latest technological developments. The aim is to foster discussion on how to tackle counterfeiting and improve patient safety.

Contact: Jasneet Tel: +44 (0) 2071129183 / +44(0)7712128928 jasneet@recunnect.net; info@recunnect.com E-mail: enquiry@lloydsconferences.com Website: www.pharmasfedubai.com Pharma Bio World

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bookshelf Supply Chain in the Pharmaceutical Industry (Hardcover) Author: Rob Whewell Price: USD 134.28 No of Pages: 200 pages About the Book: : Using examples from companies and markets across the world Rob Whewell offers a very vivid picture of the developing trends for pharmaceutical companies; the customers and markets they serve and points to some of the elements that underpin sustainable pharmaceutical strategies. The current global banking and financial crisis illustrates the important role played by regulation. The healthcare industry is similar in scope, and complexity, yet the implications of error are worse - life threatening. This review of key industry parameters will provide senior executives in the industry and policy makers in healthcare with a broad perspective of the issues and illustrates an understanding of the task at hand.

Biopharmaceutical Supply Chains: Distribution, Regulatory, Systems and Structural Changes Ahead (Hardcover) Author: Robert Handfield Price: USD 66.67 No of Pages: 272 pages About the Book: A comprehensive exploration of the massive changes in the biopharmaceutical supply chain that have occurred during the past 10 years, and predicted future trends. Based on interviews with industry professionals, the book presents an overview of the key challenges and discusses how leading biopharmaceutical companies handle these challenges. It exposes the underlying structures that support the biopharmaceutical supply chain, focusing specifically on distribution—the point at which manufacturers release a finished product to the time that it is administered, and the complicated set of channels that exist between these two points.

Supply Chain Management in the Drug Industry: Delivering Patient Value for Pharmaceuticals and Biologics (Hardcover) Authors: Leon Shargel, Andrew Yu, Susanna Wu-Pong Price: USD 60.75 No of Pages: 811 pages About the Book: This book bridges the gap between practitioners of supply-chain management and pharmaceutical industry experts. It aims to help both these groups understand the different worlds they live in and how to jointly contribute to meaningful improvements in supply-chains within the globally important pharmaceutical sector. The authors suggests that CMC (chemistry manufacturing controls) drug development must reset the line of sight – from supply of drug to the clinic and gaining a registration, to the building of a patient value stream. Capable processes and suppliers, streamlined logistics, flexible plant and equipment, shorter cycle times, effective flow of information and reduced waste. All these factors can and should be addressed at the CMC development stage.

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R.N.I. No.: MAHENG/2002/08502. Date of Publication: 26th of every month. Postal Registration No: MH/MR/SOUTH-284/2014-16 Posted at Patrika Channel Sorting Office, Mumbai 400001, on 26th & 27th of every month. Total Pages:- 54