Sandeep Singh Dhillon
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Mar
5
Sandeep Singh Dhillon
US Pharma Firms Concerned Over ‘HALAL’ Guidelines
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KUALA LUMPUR — US pharmaceutical companies have expressed concerns over the Health Ministry’s guideline on “halal” products, claiming preferential treatment.

The concern was among many issues highlighted by the Pharmaceutical Researchers and Manufacturers of America (PhRMA) in its annual submission to the US Trade Representative this month.

The report, which highlighted the challenges faced in key international markets for innovative pharmaceutical firms, was quoted by Fitch Group unit BMI Research in its follow-up publication released yesterday.

“According to (the ministry) 2017 guideline on halal pharmaceuticals, the government provides preferential treatment to medicines with halal ingredients in government procurement,” the report said.

“As such, PhRMA member companies are concerned that these guidelines could have unexpected negative implications on patients’ health.”

Last year, the Islamic Development Department of Malaysia (Jakim) became the first halal certifying body to certify controlled/prescriptive medicines (ethical products) based on the MS2424:2012 Halal Pharmaceuticals ― General Guidelines.

The current global halal pharmaceuticals prospect is valued at US$75 billion (RM331.9 billion), and estimated to reach US$132 billion by 2021.

PhRMA also complained that the ministry’s procurement process preferred locally-manufactured goods.

“The Malaysian government indirectly discourages an open and competitive marketplace for international pharmaceutical compounds through procurement preferences for locally manufactured products,” it said.

“For example, the government recently announced that it will grant three-year procurement contracts to companies that move production of imported products to Malaysia.”

This comes as PhRMA designated Malaysia a “priority foreign country”, together with South Korea in the region, complaining about what it saw as poor intellectual property (IP) protection and non-transparent compulsory licences (CLs).

“Malaysia’s designation as a ‘Priority Foreign Country’ in PhRMA’s 2018 submission highlights inadequate levels of intellectual property protection and mandatory medicine price disclosure as ongoing concerns for multinational drugmakers,” BMI said.

“Additionally, while the government has adopted a policy which prioritises the welfare of Malaysians, the use of a non-transparent process to issue compulsory licences as a method to coerce price reductions will continue to undermine investment by innovative drugmakers in the country.”

PhRMA highlighted so-called “onerous IP acts, policies and practices” and the use of CLs to promote the local production of medicines at the expense of manufacturers in the US.

“The non-transparent manner in which the announcement of the CL was made raised serious concerns as prior to the announcement, the Ministry of Health did not offer to meet with the relevant industry stakeholders to consider their concerns or evaluate their input,” BMI said.

The drugmakers stated that CLs issued by the Malaysian government “undermine a core tenant of IP protection and, if unaddressed, could inspire other countries to advance similar compulsory license schemes undermining vital IP”.

Feb
22
Sandeep Singh Dhillon
Biocon Malaysia unit gets FDA Form 483 notice – Times of India
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CHENNAI: Indian pharmaceutical giant Biocon on Wednesday told the BSE that the US-FDA (Food and Drugs Administration) has issued a Form 483 with six observations for its manufacturing facility in Malaysia.
Normally, the US-FDA issues the Form 483 when an inspection finds conditions in violations of food and drug safety. The company’s management is notified via Form 483 if the US-FDA team’s inspection has found “conditions or practices that any food, drug, device or cosmetic has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health.”
Biocon told the BSE that it would come up with a corrective action plan.
“The US-FDA has completed a pre-approval inspection of our manufacturing facility in Malaysia and has issued a Form 483 with six observations. As per the normal expectations of the agency, we intend to respond with a corrective and preventive action plan in a timely manner,” said Rajeev Balakrishnan, company secretary, Biocon.
On its website, Biocon lists its insulin manufacturing facility at Johor, Malaysia, as its first overseas biopharma manufacturing and research unit, started in 2015 with an investment of $275 million.
Biocon Malaysia, which has launched biosimilars such as Basalog and Insugen, started commercial operations in 2017 and has GMP certification from the European Medical Agency.
Biocon already supplies insulin from this plant in Malaysia and expects the insulin supplies to Europe upon product approval.
The company has received USFDA approval for Glargine and the same is likely to have triggered the inspection. The company had also indicated of the same in the recently quarterly earning conference call.
Biocon’s biosimilar version of Roche’s Trastuzumab — a drug to treat breast and stomach cancer — received US FDA approval last December.

Feb
8
Sandeep Singh Dhillon
60-Year-Old Drug May Hold Clues To Stopping Spread Of Breast Cancer – Forbes
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By Victoria Forster , CONTRIBUTOR

One of the oldest chemotherapy drugs in the world may be able to stop breast cancer spreading, according to a study published today in the journal Nature.

As with many types of cancer, most people who die of breast cancer do so not because of their primary tumor, but because their cancer spreads to other organs. For this to happen, the cancer cells must leave the original tumor, enter the bloodstream and then settle and grow in other organs. Once cancer has metastasized like this, the chances of survival are drastically lower than in individuals without metastasis.

Researchers at the Cancer Research UK institute at Cambridge University, U.K. found that giving L-asparaginase to mice and limiting the asparagine they consumed in their food greatly reduced the spread of breast cancer cells. It works by blocking the production of an amino acid called asparagine, which can be produced in the body by an enzyme called asparagine synthase or consumed in food. To confirm this, the scientists used RNA interference to block the production of asparagine synthase and found similar effects on the spread of the breast cancer cells.

L-asparaginase has been used for decades to treat children with leukemia and was originally pioneered in the 1950s after it reduced the growth of lymphomas in rat models. Some children with a particular type of leukemia show resistance to L-asparaginase and this has previously been linked to their levels of asparagine synthase, so the researchers examined data on breast cancer patients, which indicated that breast cancer cells that were able to make lots of asparagine were more likely to spread.

Professor Greg Hannon, lead author of the study, said: “Our work has pinpointed one of the key mechanisms that promotes the ability of breast cancer cells to spread. When the availability of asparagine was reduced, we saw little impact on the primary tumor in the breast, but tumor cells had reduced capacity for metastases in other parts of the body.”

In the future, the scientists hope that nutritional interventions such as limiting asparagine, which is found in high quantities in soy, dairy, poultry and seafood, might stop the disease spreading and improve overall survival. However, specialists are keen to advise against breast cancer patients drastically changing their diets as a result of these new findings.

Martin Ledwick, Cancer Research UK’s head nurse, said: “Research like this is crucial to help develop better treatments for breast cancer patients. At the moment, there is no evidence that restricting certain foods can help fight cancer, so it’s important for patients to speak to their doctor before making any changes to their diet while having treatment.”

L-asparaginase is not the first “old” drug for which scientists have found new potential uses. Thalidomide, the much-maligned drug responsible for serious birth defects after being given to pregnant mothers in the 1960s is now being used as an FDA-approved treatment for multiple myeloma and is in clinical trials for seemingly every other imaginable type of cancer.

Aspirin is also a hot research topic currently, proposed to prevent some types of cancer and big-hitting research institutions such as St. Jude’s in Memphis, focusing on childhood cancer, have entire research programs dedicated to repurposing existing drugs for new treatment possibilities.

With so much focus on new treatments, this is yet another reminder that successful cancer treatments might be already right underneath our noses.

This article originally appeared at https://www.forbes.com/sites/victoriaforster/2018/02/07/sixty-year-old-drug-may-hold-the-key-to-stopping-spread-of-breast-cancer/#b9159e8423e8

Feb
2
Sandeep Singh Dhillon
What Challenges Should Biosimilar Companies Expect In 2018? – Biosimilardevelopment.com
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By Anna Rose Welch, Editor, Biosimilar Development

What challenges do you expect biosimilar companies to run into in 2018, and what could be done to address these challenges?

A sustainable biosimilar medicines industry implies access to the global market, or at least a multi-region market. In the EU, the European Commission will undertake a debate on pharmaceutical incentives, which is a cornerstone to competition in the pharmaceutical and biologics market. One of the measures at stake, the supplementary patent protection manufacturing waiver, is of fundamental importance for biosimilar manufacturers established in the EU. The change would leave the EU IP landscape unaffected while, at the same time, enabling manufacturers to compete globally for markets where IP protection no longer exists, removing an unintentional adverse effect of the current legislation. This is particularly important in light of the key biologic product monopolies for which expiry is coming. The biggest of all challenges, in my opinion, will be for EU governments and policy makers to put their ambitions in motion, be it for competition in the biologics market or for EU industrial policy. Rather than grand plans and national policies, it may be important to start with small and tailored, yet concrete, policies so the benefits are tangible in a shorter time frame.

Julie Maréchal-Jamil, director biosimilars policy & science, Medicines for Europe

An ongoing challenge for companies will be considering commercialization challenges and solutions as well as policy and reimbursement trends and scenarios from the moment of product selection. Too many companies have focused entirely on selecting, developing, and investing in products alone, but this is not enough. Companies also have to build a strategy around a true path for differentiation and be clear as to what parts of the value chain will be owned by whom. Hence, you have to engage business development much earlier in the process. Waiting too long to do so greatly lowers options and returns while increasing risks and the possibility of early mistakes, even as far back as portfolio selection itself. In short, development and regulatory success are necessary but certainly not sufficient. One must engage more fully and proactively in policy and commercialization challenges and solutions — not just alone, but with partners and trade associations.

Edric Engert, managing director, Abraxeolus Consulting

Biosimilars will enable patients with active rheumatoid arthritis and inflammatory bowel disease to get the treatment in its early stages. For patients with lymphoma or breast/gastric cancer, biosimilars can improve access to therapeutically aggressive rituximab- or trastuzumab-based combination regimens. However, physicians and patients continue to emphasize concerns about switching from biologics to biosimilars. Therefore, biosimilar companies must have robust evidence to reassure the medical and patient community about the safety and efficacy of switching. For instance, studies like the NOR-SWITCH study or the pivotal randomized controlled trial of CT-P13 in Crohn’s disease have made a significant contribution to the evidence base for switching.

— HoUng Kim, head of strategy and operations, Celltrion

Market access remains a challenge for biosimilar companies, with patients, pharmacists, and physicians still unsure about biosimilars. Knowledge about and understanding of biosimilars and their development pathway are still lacking, and more education is required at a broader and deeper level. Stakeholders such as payers, regulatory agencies, and others in the healthcare sector should actively promote the use of biosimilars, explaining how they can promote sustainability of the healthcare system. In the EU, gainsharing has certainly helped the uptake of biosimilars, whereby the savings generated by patients taking biosimilars are shared between providers and payers. This acknowledges the efforts by providers in either initiating or switching patients to a biosimilar.

Sue Naeyaert, global head of pricing, market access, government affairs and policy, biosimilars, Fresenius Kabi SwissBioSim

One main challenge I expect biosimilar companies to run into in 2018 will be effectively balancing pricing that will enable profits and gain commercial payer reimbursement and management support. Biosimilar companies may face challenges to provide lower net-cost pricing relative to competing reference biologics in order to gain support from some commercial health plans. It is important to note this challenge does not apply to Medicare, because Medicare Advantage plans are restricted from providing utilization management support (though this actually could help increase market share for Part B biosimilars).

— Brian Lehman, strategic consultant, Humana Pharmacy Professional Affairs

One of the big challenges at the moment is finding enough patients to accommodate the requirements for clinical trials, seeing as more companies are bringing mainstream biosimilar drugs, such as anti-inflammatory drugs, into Phase 3 clinical trials. One way to address the challenge is by accessing patients in other geographic locations who haven’t been treated with these drugs, such as Eastern European countries, where the quality of medicine is high and standardized laboratory tests can be run at another site, such as in Western Europe. In the U.S., administrative burdens, such as documentation requirements and physician sign-off, can interfere with supporting patients in a clinical trial. This challenge could be addressed by streamlining the documentation required and presenting a harmonized approach to data collection and reporting, with support from regulatory agencies and industry associations.

Don Stewart, CEO, PlantForm

Patent litigation will continue to dampen the growth of the biosimilar market in the U.S. I’d argue public interest litigation and political pressure would help the situation. In general, a stronger biosimilar lobby would help significantly.

Pankaj Mohan, CEO, Oncobiologics

In my opinion, the greatest challenges biosimilar companies will face in 2018 are acceptance, patent challenges, and developing a successful marketing plan. A critical challenge facing biosimilar companies will be to educate the broader healthcare professional community and then patients about the basics of biosimilars. By necessity, education has until now focused on some professional societies and patient groups. While it is heartening to see an increase in their knowledge and acceptance, it will be more challenging to broaden this knowledge to the rank and file of healthcare professionals and to the ordinary patient so that biosimilars will be broadly accepted.

It has also become apparent that the thicket of patents surrounding reference products will delay the entry of many biosimilars. I am not an expert on patents, but still I recognize that negotiating a path forward in this area will be critical. Adoption of biosimilars in the U.S. once they are launched will also be a challenge. Zarxio has a very respectable market share two years after product launch, but it seems other biosimilars are facing challenges in adoption.

— Hillel Cohen, executive director, scientific affairs, Sandoz

*These statements represent the viewpoints of the individuals, not those of their employers.

This article originally appeared at https://www.biosimilardevelopment.com/doc/what-challenges-should-biosimilar-companies-expect-in-0001?vm_tId=2047638&user=c666d828-d506-40aa-bb3a-c74525efd4db&utm_source=et_6384992&utm_medium=email&utm_campaign=BIOS_02-01-2018&utm_term=c666d828-d506-40aa-bb3a-c74525efd4db&utm_content=What+Challenges+Should+Biosimilar+Companies+Expect+In+2018%253f

Feb
1
Sandeep Singh Dhillon
If Amazon And Buffett Lift Veil On Health Prices, Insurers Are In Trouble – Forbes Healthcare
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By Bruce Japsen , CONTRIBUTOR

Jeff Bezos’ Amazon and Warren Buffett’s Berkshire Hathaway are forming their own healthcare company with JPMorgan Chase to increase transparency for their employees, and that could be bad news for insurers and pharmacy benefit managers.

Health insurance companies and PBMs have long said they want to bring more transparency to the U.S. healthcare system, yet consumers often don’t know the true cost of healthcare. Prices are negotiated in secret and doctors don’t often know what their own services cost or what their patients will be charged.

Details of the new company the three corporate giants want to create remain sketchy, but the idea that they want to bring more transparency is one of the disclosed goals. “Our people want transparency, knowledge and control when it comes to managing their healthcare,” said Jamie Dimon, Chairman and CEO of JPMorgan Chase.

Those who’ve been engaged in the struggle to find the true cost of healthcare have been working for years with limited success. Often times, they have difficulty getting data from health plans or medical care providers.

“Resistance to transparency in healthcare remains high,” says Network for Regional Healthcare Improvement CEO Elizabeth Mitchell, who welcomes Amazon, Berkshire and JPMorgan’s new company. “Employers who pay for this care still don’t have insight into the relative value of what they are buying. They are looking for a way to have assurance that they are paying a fair price for a high quality service.”

The Network for Regional Healthcare Improvement has long said any health reform effort needs to look closely at transparency because data that reveals the total and true cost of care is difficult to find. In a report last year, NRHI said health spending by U.S. commercial insurers can vary by $1,000 or more per year per patient, depending on where enrollees live.

The potential for the Amazon-Berkshire healthcare company to disrupt the way health plans do business is one reason shares of many healthcare companies tumbled Tuesday after the partnership was announced.

Shares of insurers like Aetna, Anthem and UnitedHealth Group lost 5% to 10% of their value while pharmacy chains CVS Health, Walgreens Boots Alliance and drug makers with expensive medicines like Abbvie also took a hit on Wall Street. And the big PBM, Express Scripts, also lost more than 2% of its value Tuesday.

Nobody knows for sure what Amazon, Berkshire and JPMorgan have in mind because they said their effort is in its “early planning stages.” The trio tapped three executives to get the company off the ground: Todd Combs, an investment officer of Berkshire Hathaway; Marvelle Sullivan Berchtold, a Managing Director of JPMorgan Chase; and Beth Galetti, a Senior Vice President at Amazon. No further details were disclosed, including where the company would be located.

Some think Amazon could leverage its technology platform to make a dent in the healthcare cost curve and improve transparency.

“Amazon may spur new technology innovations” such as artificial intelligence or information sharing platforms that “can increase the efficiency of healthcare delivery,” said Idris Adjerid, a management IT professor in the University of Notre Dame’s Mendoza College of Business. “Our research substantiates this potential value. We find that technology initiatives, which facilitated information sharing between disconnected hospitals resulted in significant reductions in healthcare spending.”

Studies show 30% of the money spent on healthcare is waste. Amazon, Berkshire and JPMorgan said the initial focus will be on “technology solutions” that will provide U.S. employees and their families with “simplified, high-quality and transparent healthcare at a reasonable cost.”

But given Amazon’s popularity among consumers and the decades of success Buffett has built with his businesses, the executives say improving patient experience and customer service will also be a target of the new company.

“These businesses understand customer service,” Mitchell of the Network for Regional Healthcare Improvement said of Amazon, Berkshire and JPMorgan. “Reorienting healthcare to being customer focused is exactly what is needed and will require massive and overdue change.”

This article originally appeared at https://www.forbes.com/sites/brucejapsen/2018/01/31/if-amazon-and-buffett-lift-veil-on-health-prices-insurers-are-in-trouble/#6a8a085141c0

Jan
25
Sandeep Singh Dhillon
Sr. Manager, R&D at Germer International Billings, MT (Monster.com)
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About the Job

Do you love being outdoors and want to get away from the hustle and bustle of a larger town??? If so, you may be interested to know that Germer International has a client located in one of the most beautiful parts of the country where those outdoor recreational activities is available to you right outside your front door. A growing API manufacturing organization located in the Midwest is seeking an expert Process Development Scientist who has industry experience in overseeing a team of R&D Scientists (both Analytical Development and Process Development) to come aboard and join their team. The Sr. Manager, R&D will be involved in the tactical responsibilities of overseeing and developing staff in the lab while working closely with the VP, Product Development in tackling process improvement initiatives and pipeline development.

What does this mean to you????

·An opportunity to lead, mentor, and coach the R&D department consisting of skilled and experienced Scientists in the industry (mainly PhD-level)

·An opportunity to work in a smaller environment that brings a strong family feel and where the team mentality is a strong aspect of the company culture

·Outdoor recreational activities (hiking, horseback riding, camping, fishing, etc…) are right at your fingertips

·Competitive salary, bonus, & relocation assistance provided

Essential Duties and Responsibilities

Provide guidance and oversight to ensure that newly developed manufacturing and product testing processes are state-of-the art, cost-effective, robust, and well-defined.
Through resource and long-term planning, ensure that R&D resources are allocated appropriately to support company goals and long-term strategy, that project deliverables are met, and that development is completed in accordance with ICH Q11 and company policies.
Interact effectively with cross-functional teams, including Project Management, Product Development, QC, QA, Operations and other internal and external development groups.
Conduct patent reviews and work with patent attorneys to ensure that future processes will have freedom to operate and that newly developed IP is appropriately protected.
Conduct feasibility analyses to determine optimal processes for further development.
Write, review, and/or approve scientific documentation, including development reports and regulatory documents in accordance with company policies.
Perform complex laboratory activities including planning and performing experiments, including Design of Experiments, and research for novel processes to produce APIs.
Ensure that analytical test methods used in R&D are scientifically sound and suitable for their intended use throughout the development process and that test methods intended for transfer into QC are able to be validated in accordance with ICH requirements.
Conduct troubleshooting, participate in risk assessments, and provide technical assistance for NPD project teams, Operations, and Quality Control.
Ensure that the R&D laboratory has supplies and organization to perform the assigned work, and is operated in accordance with OSHA, cGMP, DEA, and company policies.

Education/Experience:

·Ph.D. in Chemistry required; with at least 10 years of organic synthesis experience including at least 10 years in a leadership role.

·At least 5 years of experience in analytical method development and validation preferred.

·Research and Development experience in the pharmaceutical industry, specifically in the development of active pharmaceutical ingredients, strongly preferred.

Please apply at https://job-openings.monster.com/Sr-Manager-R-D-Job-Billings-MT-US/11/192379224

Jan
25
Sandeep Singh Dhillon
Senior Analytical Development Scientist at Germer International Cedar Rapids, IA (Monster.com)
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About the Job

Our Client is a $300MM Pharmaceutical organization who has shown continuous success and improvement throughout their years of operation. Their serious commitment to high-quality standards has been proven through the products & services they provide via one of their manufacturing facilities, located in the Midwestern region of the US. They continue to strengthen that commitment through acquisitions and expansion projects across all of their domestic and international sites. Their mission is to continue to being aboard experienced professionals within the Pharmaceutical industry to oversee core elements of their operation. They are currently seeking Sr. Analytical Development Scientists who will provide technical support and leadership to multiple project teams. The Senior Analytical Chemist will evaluate and interpret analytical results, develop, validate and transfer analytical methods for APIs, API intermediates and raw materials. Strict compliance with cGMP guidelines is required to perform most job tasks.

Job Responsibilities

With minimal supervision, safely and effectively develop, establish, and validate analytical testing methodologies used to control raw materials, production intermediates, and final products.
Investigate and solve analytical technical issues within Analytical Development, Chemical Development, Process Support Group and Quality Control.
Perform analytical chemistry assays based on new and existing methodologies
Operate analytical instrumentation such as HPLC, GC, GC/MS, FTIR, Titrator, Particle Size Analyzer
Write technical reports to document analytical methods
Maintain laboratory notebooks documenting work
Maintain compliance with GMP SOPs and DEA regulations
Transfer documented analytical methods to the QC and Process Support Group departments
Set up new or existing analytical methods for compound identification, purity and potency testing.
Coordinate off-site testing as necessary
Conduct testing of analytical samples for the Chemical Development Department as necessary.
Qualify reference materials.

Job Qualifications

Advanced Chemistry degree desired, with a PhD preferred
Minimum BS degree in Chemistry or closely related field required, with 7+ years of experience in manufacturing support laboratory
Experience with dissolution and chemosensory testing highly desired
Familiarity with compliance requirements within cGMP, safety and regulatory environments
Operational knowledge of analytical instrumentation like HPLC, GC, GC-MS, FTIR, UV-VIS equipment, and data stations required
Demonstrated computer literacy, including word processing, spreadsheets, structural drawings, and databases preferably in a Windows environment
The ability to solve extremely complex problems where analysis of situations or data requires an evaluation of intangible variables
Ability to work in a highly independent and self-directed work environment.

Please apply for the job at https://job-openings.monster.com/Senior-Analytical-Development-Scientist-Job-Cedar-Rapids-IA-US/11/192379211

Jan
25
Sandeep Singh Dhillon
Engineering Manager (Pharmaceutical Industry) at Germer International Buffalo, NY (Monster.com)
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About the Job

Germer International’s client, a $6B Pharmaceutical organization already recognized as one of the top three pharmaceutical companies manufacturing generic controlled substance sterile injectable products here in the US, is actively looking to expand their engineering team. Due to major growth of their organization, they are greatly expanding their state-of-the-art facility and need qualified Pharmaceutical Engineers who understand sterile operations to come aboard and join their team. They are actively looking foran Engineering Manager who will be responsible for managing the engineering team as well as engineering functions including plant engineering, project management, and computer aided drawing and design. The team will comprise of Manufacturing and Project Engineers, CAD personnel, Technical Writers, Mechanics/Electricians, and Administrative staff who will work together to improve plant quality, operational efficiency/effectiveness, capacity, capability, and modernization objectives.

Responsibilities:

Responsible for the design, procurement, installation, and improvement of site manufacturing and utility equipment as well as facility upgrades and expansions in a cGMP environment.
Responsible for the design, fabrication/construction, and implementation of upgrades to existing and/or new facilities, utilities, and equipment.
Manage projects such as the design and installation of new or upgraded manufacturing lines and utility systems.
Manage the startup of new processes and technologies such as lyophilization, clean in place (CIP) / sterilize in place (SIP), water systems, waste systems, and utility systems.
Manage the design and construction of new and renovated facilities.
Manage departmental and capital budgets.
Manage day to day engineering support functions such as project development and drawing updates/requests.
Assist maintenance and operations in problem solving and process improvements.
Maintain cGMP, OSHA, and DEC compliance through implementation and adherence to SOP’s and governmental regulations.
Initiate, author, review, and approve change control, specifications, risk assessments, work orders, standard operating procedures (SOPs), capital project approvals (CPAs), purchase requisitions/orders, factory/site acceptance tests (FAT/SAT), corrective actions, and associated interim/final reports and other paperwork in compliance with Company policy.
Manage the preparation and approval of validation protocols for new and upgraded equipment, facilities, and utilities.
Review final documentation packages for all major systems at the plant including, but not limited to utility systems, filling operations, packaging operations, dry heat sterilization/depyrogenation, steam sterilizers and process washers.
Participate in and resolve audit and regulatory deficiencies.
Serve as reviewer and approver for deviation investigations
Hire, develop, organize and lead staff.
Establish and implement appropriate engineering staff training requirements.
Requirements:

BS in an Engineering/technical discipline required, masters preferred. MBA a plus.
Minimum of 5 years of experience in an engineering and/or cGMP manufacturing environment, preferably a pharmaceutical environment
Knowledge of all aspects of manufacturing processes, automation and controls such as PLCs and HMIs, machine design and layout, utilities and piping including compressed air and gasses, steam and water systems, HVAC, fire protection, project management, Autocad, construction, drawing standards including the ability to read and decipher drawings including process and instrumentation (P&ID), and general supervision.

Please visit https://job-openings.monster.com/Engineering-Manager-Pharmaceutical-Industry-Buffalo-NY-US-Germer-International/11/192647339 to apply

Jan
25
Sandeep Singh Dhillon
Novartis Climbs Out of Its Growth Pit – Bloomberg Gadfly
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Its new CEO has challenges but is starting from a good place.

By Max Nisen

Incoming Novartis AG CEO Vas Narasimhan is taking over at the right time.

As it reported fourth-quarter earnings on Wednesday, the company predicted it will grow sales in 2018 after a multi-year slump. Departing CEO Joe Jimenez is leaving many difficult decisions for Narasimhan as he cedes control next week. But he is also leaving a company with an unusually rich set of assets and a pretty high margin for error.

One of Jimenez’s nicest parting gifts is a return to sales growth for the company’s troubled Alcon eye-care division. That makes the decision (delayed until 2019) to sell or spin off the unit less urgent; it’s no longer an obvious drag on the share price. And there’s real hope of increasing the return of an eventual divestiture by further improving results.

But generics unit Sandoz has emerged as a new problem child, hurt by a difficult pricing environment. U.S. sales fell 17 percent in the fourth quarter from a year ago, Novartis said Wednesday. Narasimhan on the earnings call outlined a strategy to help Sandoz, moving away from products most subject to pricing pressure and toward more-complex (read, expensive) alternatives. But several other generic drugmakers are pursuing the same strategy, and it won’t be an easy or quick fix.

Sandoz’s success depends largely on the progress of Novartis’s heavy investment in biosimilars — the equivalent of generics for complex drugs made in living cells. But it’s far from alone in that endeavor, and the lucrative U.S. market is proving highly difficult and time-consuming to crack.

On the novel drug side — the source of 67 percent of Novartis’s revenue in 2017 — Narasimhan will inherit a broad set of new medicines to help overcome sales declines of older stalwarts such as Gleevec. But heavy competition awaits. Cosentyx, the firm’s best recent launch, is fighting it out in psoriasis with both well-settled blockbusters such as Humira and newer drugs such as Taltz and Tremfya. Breast-cancer drug Kisquali and an upcoming migraine medicine are also in intensely competitive classes.

Pharmacy benefit managers will likely have a field day extracting big discounts on these drugs, and the marketing battles will be fierce.

Novartis’s heart failure drug Entresto has been dogged by payer restrictions since its 2015 approval due to its cost and large patient population. It’s still far from the company’s diminished $3 billion plus estimate of its potential peak sales.

Still, at least Novartis has new drugs. Some of its medicines are in less-competitive markets. And while I am constitutionally skeptical of Narasimhan’s claims that the company will boost productivity via investment in automation and AI, his pledge to prune the firm’s research pipeline more aggressively is promising.

Though Novartis hasn’t done much on the M&A front, it has the capacity to invest if pharma growth lags once more or if Sandoz proves tough to fix. Its balance sheet is strong. And it can generate a flood of cash by selling out of its consumer joint venture with GlaxoSmithKline PLC and its separate multi-billion-dollar equity stake in Swiss rival Roche Holding AG. It could also speed up its decision on what to do with Alcon.

But its financial position gives it the luxury of waiting for the best return on these disposals while enjoying a cheap boost to its income in the meantime.

There are pitfalls ahead for Narasimhan. But at least he’s not starting in one.

This article originally appeared at https://www.bloomberg.com/gadfly/articles/2018-01-24/novartis-earnings-climbing-out-of-a-growth-pit

Jan
8
Sandeep Singh Dhillon
New Study Shows How Alcohol Damages DNA – Forbes
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Victoria Forster

Those abstaining from alcohol this month now have extra reason to be smug as a new study, published today in Nature sheds light on how alcohol damages DNA and increases the risk of cancer.

Scientists and doctors have previously linked alcohol to an increased risk of developing at least seven types of cancer, and attribute it to causing almost 20,000 cancer deaths in the USA per year, but until now, the exact way in which alcohol damages DNA has not been clear.

Scientists at the MRC Laboratory of Molecular Biology in the UK gave ethanol, the type of alcohol found in alcoholic beverages, to mice and then looked at their DNA to see what genetic damage had been sustained. They found that acetaldehyde, a breakdown product of ethanol, damaged the DNA within blood stem cells, leaving them riddled with mutations that could lead to cancer.

Professor Ketan Patel, the lead author of the study, said: “Some cancers develop due to DNA damage in stem cells. While some damage occurs by chance, our findings suggest that drinking alcohol can increase the risk of this damage.”

The study also investigated how the body breaks down alcohol and how this contributes to the risk of DNA damage after indulging. Aldehyde dehydrogenases (ALDH) are a group of enzymes which break down acetaldehyde into benign acetate, which can actually be used as a source of energy for cells and hence is a large part of the unfortunate calorie-burden of alcohol.

Worldwide, over half a billion people lack or have mutations in ALDH genes, meaning that after drinking, they get a build up of acetaldehyde, which also gives them a flushed complexion and can mean they feel unwell. People most likely to have these mutations are often of South East Asian heritage, including millions of Americans, but the deficiency can occur in people of any ethnicity.

The researchers gave ethanol to mice lacking ALDH2, the most important ALDH enzyme, and found that these mice had four times as much DNA damage in their cells when compared to mice who had the fully-functioning ALDH2 enzyme. This research adds to work that has previously suggested that people with ALDH2 deficiency were at greater risk of developing esophageal cancer after drinking.

The American Cancer Society recommends a maximum of one drink a day for women and two for men. However, this new study adds to a wave of recent expert opinion and evidence which suggests that there is no ‘safe limit’ for alcohol consumption and even minimal drinking will cause some level of DNA damage.

This article originally appeared at https://www.forbes.com/sites/victoriaforster/2018/01/03/not-doing-dryuary-you-might-want-to-reconsider-as-new-study-shows-how-alcohol-damages-dna/?ss=pharma-healthcare#7bbfa7ae50f6