July 1, 2014

6 Tips for Controlling Costs When Engaging a Consultant or Expert Witness

The right expert witnesses can be a key component to helping an attorney win a case. A great deal of attention is paid to finding and contracting with a good expert. While hourly rates may seem high and a large number of hours may be needed for an expert to review the facts of a case and provide a meaningful written opinion, there are ways you can manage the engagement of an expert to keep costs at a minimum.

1. Don’t give your expert more documents to read than necessary – this can drive up charges if the consultant has to spend time reading unnecessary documents

2. Don’t lead expert opinion. While you may have a case strategy, leading or influencing the report can place the expert in an ethical dilemma if he disagrees with your conclusions, require additional research to support, and add to time spent on the case. If you have selected the right expert, allow them to present their professional opinion to you without a requested outcome.

Presenting your case strategy when interviewing a potential expert can let you know if the expert is likely to be on your side, without influencing him. If the expert feels as if his/her opinion has been influenced, he/she may be required to disclose this in court, which may hurt your case.

3. Be easy to contact. This will eliminate delays while the expert is waiting to have questions answered and time charges for multiple contacts.

4. Pay your bill on time. This keeps the consultant focused on the job rather than on following up on payment.

5. Make sure the scope of the project or case is clearly defined.  Being on the same page from the start of the project will help insure that your expert or consultant is working on the tasks most important to your case or project.

6.  Communicate frequently to insure the project is on track and that key deadlines and trial dates are on everyone’s calendar.

For more hands on tips on managing expert witnesses, see our three part series Guidelines for Your Expert Witness and other Expert Witness Management Tips on this blog. This series is also available as a Whitepaper; call our offices or email us at info@cecon.com to request a copy.

Founded in 1985, The CECON Group specializes in providing science and engineering consultants and expert witnesses. Consultants in their global network typically have more than 25 years of experience; CECON offers consultants in more than 200 disciplines, including pharmaceutical development and regulatory compliance, chemical processing and safety, biotechnology, medical devices, nanotechnology, and polymers and coatings.

For details, visit www.cecon.com or call 888-263-8000.

June 17, 2014

Case Study: A New Design for a Water-Cooled Furnace Brings to Life the Concept of “Conservative Innovation”

When a CECON consultant specializing in chemical and process engineering presented his idea for a new design for a water-cooled furnace to the expert designers he worked with they said one word: IMPOSSIBLE.  But employing his concept of “conservative innovation design,” he persisted and built a furnace that not only operated successfully, it became far more practical to maintain and repair than the traditional design.

Over the course of five years, I have built and operated a total of seven rotary induction water cooled furnaces—giant furnaces capable of processing hundreds of tons of ore per hour—in two different factories.  

When No. 6 was running, my electrician, who I had been working with since No. 1, came into my office and declared: “We must get rid of this water cooling nuisance. You must make an air-cooled coil!” He had a point. Water leakages and sometimes blocked water passages, created safety risks, demanded problematic repairs and consequently caused lengthy down time of the furnaces.

I immediately responded: “Our furnaces are not the first in the world. If this were possible, the Chinese experts who supplied the equipment would have done it long ago. Forget about it! We have enough on our hands.”

He was disappointed, but he understood my point.

But that evening I found myself considering the possibilities. I started writing notes and making sketches. I assumed that if this was really impossible, my engineering calculations would run into a dead end, or some expert will convince me to let go of the idea.

My criteria were that I need the new design to be suitable for conversion of the existing furnaces without major modifications including the need to modify the power supply and control mode. Getting rid of the cooling water nuisance was tempting but not enough to justify a major design revolution, especially considering that we already 6 furnaces running.

It took some calculations and consulting with experts of heat exchange and electrical bus bar designers to come up with an alternative design of an air-cooled coil that would have the same Ohmic resistance as the original despite of the higher working temperature. The copper weight was 2.5 times the original. More expensive but still not prohibitive. I now knew that I had a suitable design.

We knew the maximum current in the coils so we could calculate the power needed to overcome the Ohmic resistance of the coils. We then measured the cooling water flow rate and temperature difference and thus verified that we know the heat load to be removed by the surrounding air. With this in hand, and using some heat exchange coefficients found in literature, we could calculate the surface temperature of any suggested copper profile to be used for the construction of the new AIR-COOLED INDUCTION COIL. 

Knowing the service temperature of the Copper we could now find the new specific resistance of the Copper and calculate the required cross section in order that the total coil resistance will be the same as the original. The copper weight was 2.5 times the original. More expensive but still not prohibitive. I now compared my results to engineering tables which I received from an electrical engineer showing service conditions and loads for bare copper cables and bus bars used in electrical panels. The comparison was encouraging. I now knew that I had a suitable design.

What is Conservative Innovative Design?
At this stage I would like to spell out the main characteristics of what I call Conservative Innovative design. The innovative part of this is easy to understand. Once you face a problem, which the existing technology cannot solve satisfactorily, keep your mind open to innovative ideas even if, at first glance they look unsuitable. Do not be afraid of innovation. Have the guts to try new things.

How do you apply innovation in a conservative way? We must remember that we are within an operating facility where a lot of money was invested and time is highly valued. We must respect the “old” technology even if we are critical of it, as this is actually what we have and what is paying the bills and providing pay checks.

We must not be too adventurous or too arrogant. We must consult with many experts, listen to many opinions, especially those which reject our ideas and predict failure. We must be critical to prove to ourselves that the rejecting opinions are wrong–or maybe they are right or partially right and maybe we can learn something and improve. This requires patience and hesitation. A thinking process that does not go through the hesitation stage had simply not been examined deeply enough. Never assume that things will go right. Prove it to yourself!

June 3, 2014

The Best Way to Source Consultants/ Legal Expert Witnesses: Social Media or Placement Firm?

5 Advantages of (and 1 Misconception about)
Using a Consultant Placement Firm over Searching Social Media to Hire a Consultant

 With everyone on Linked In and websites so easy to build, it is easier than ever to search for a client or expert on the internet and skip the “middleman” or expert placement firm when hiring a consultant. But should you? Is it really cheaper? 

What are the advantages to using an expert placement firm?

1. Vetting. Did the expert whose profile looks so appealing on social media really attend that school? Does he/she really have those skills? A placement firm can vet their experts.

2. Additional experts are available if needed. If you need multiple experts or additional experts in a complementary field,  a placement firm can be “one stop shopping.” Your “rep” will already know the details of your project and the expertise you already have, so you don’t need to start over multiple times to engage additional help. You will also just get one invoice, which streamlines paperwork for you.

3. Filtering: Having so many choices of experts can be confusing. A placement firm with experience in a specific practice area is able to help you discern which of a long list of experts is the one who meets your needs. Experts may use a variety of terms in their resumes or websites, whose relevance may be difficult to interpret for someone not in that field. A placement firm can send you a filtered list of candidates.

4. Expertise discernement: What type of expertise is actually needed for your job? It may be different than you think.
In one of CECON’s successful expert placements, a plaintiff’s attorney sought a pharmaceutical consultant with a specific skill set from our expert database. After discussing the case with the client and getting more details, the CECON Project Manager suggested that an expert with a slightly different background would be more appropriate. An expert on regulatory issues and innovative/generic drug labeling was engaged, per CECON’s suggestion. The outcome was a judgment was for the plaintiffs, with a $500 Million Punitive Award.

5. Scope definition. A placement firm whose client service reps have expert experience themselves can often help define and narrow the scope of your job.
For example, CECON Project Managers have helped clients define technical specifications for engineering projects, then sourced the necessary consulting team to complete the projects. If you are uncertain about the full scope and hidden tasks involved with a project, an experienced technical project manager can help you.

And, the one misconception: that fees will be higher. This is not always the case. Fees may be comparable to hiring an expert directly when sourcing a consultant through a placement firm. Because placement firms provide a higher volume of work to a consultant than one client will, they may get a lower rate, which compensates for the placement fee. Placement firms usually understand market pricing and will work to make the net end fee to the user competitive.

So don’t rule out using a placement firm because you think the fee may be higher. The services provided will also save you time in searching, another cost savings.

Founded in 1985, The CECON Group specializes in providing science and engineering consultants and expert witnesses. Consultants in their global network typically have more than 25 years of experience; CECON offers consultants in more than 200 disciplines, including pharmaceutical development and regulatory compliance, chemical processing and safety, biotechnology, medical devices, nanotechnology, and polymers and coatings.

For details, visit www.cecon.com or call 888-263-8000.

May 19, 2014

Research News: What’s on the Horizon for the Controversial Medical Stent?

About 500,000 angioplasties are performed in the United States every year. Dr. Stanley Tocker, a CECON Group Vice President and consultant in this controversial subject area, reports on important happenings in the research of stents.

Medical stents, small expandable mesh tubes used to open narrowed vascular sites or support weakened vessels, have been in the news in the face of multiple lawsuits and two leading medical societies publishing a report calling stents “one of the five most overused procedures in medicine.” The report called into question elective procedures versus emergency situations using stents for patients having heart attacks—where the life-saving benefit is clear.

Angioplasty typically costs around $30,000, and in rare circumstances it can lead to tears in blood vessel walls, bleeding and the formation of blood clots.

All aspects of the stent design, surgical techniques for their use, anti-plaque coatings, coating methodology and materials of construction have been studied. One aspect of stents where some fascinating research is currently taking place is in the material choice.

Most stents are made of stainless steel mesh coated with drug eluting coatings containing drugs that resist plaque formation at the stent site (restinosis). Other than stainless steel, decomposable metals are being tested for the base platform such as magnesium, iron, zinc and tailored metal alloys. The idea is to have the stent physically break down over time, leave the patient and not act as a possible site for reclogging (restenosis) as might be expected for a foreign body in the vascular system.

 Chemists are also currently studying polymeric materials for stents that dissipate over a predetermined time frame. Initially, this work has involved polymers based on polylactic acid, used in dissolvable sutures, but it has branched out to other polymers. Such systems can have minimal systemic toxicity because the breakdown products can be similar to those already present in vivo. For example, lactic acid copolymers such as those having glycolic acid units are being studied as well other non-toxic proprietary systems. These “dissolvable” systems also have been accompanied by anti-plaque drugs used within or as coatings.

The goal in these non-stainless steel stents is to maintain the proper strength to survive the surgery ,  show favorable  ductility, dissolution rate and anti plaque character.  Considering that these are critical interrelated factors, this is extremely difficult but important research.

Other questions arise such as if everything works well, with dissolvable or biodeecomposible stents, will the application site “bloom” again and become restricted.  After all, the on-site plaque is being compressed by the stent, and not being removed. Of course the patients’  individual genetics, age, diet and other human factors also add to the technical uncertainties and difficulties.

A dissolvable stent is already used in Europe. Depending on the results of current research, it could be approved here in a few years. Will dissolvable or biodeecomposible stents totally replace metal stents? Probably not. But it is potentially a breakthrough innovation in a well-tested therapeutic area.

 Dr. Tocker consults in this subject area and is a vice president of the CECON Group. Since 1985, The CECON Group has been placing experts in over 200 scientific disciplines. CECON Consultants include medical device expertspharmaceutical consultants, clinical trials expertsbiotechnology expertsand chemistry experts.

May 1, 2014

Questions to Ask when Hiring an Expert

When hiring an expert for a consulting project or expert witness testimony in a legal case, it is important to ask the right questions, in the right order, to obtain relevant information to make the best choice.

We asked CECON Vice President and placement specialist Barry Bowen, as well as one of our long-time consultants, a former FDA Science Branch Manager, what they believe the most important questions are to ask potential candidates:

1. Do you have any potential conflicts of interest with any of the parties, such as previous employers? This could include cases you have been involved with, etc.

2. After describing the case: Can you handle this case?

3. Are you available to assist during the required timeframe?

4. What is your experience with the subject matter? This should include discussions of relevant and related background in the subject matter, such as chemistry, clinical studies, device production, packaging, CMO, CRO, quality, regulatory compliance, etc.
5. Do you have a tendency to support client technical views for legal cases? Or are you able to be objective and unbiased?

6. What is your previous experience as an expert witness? Describe your activities surrounding consulting, reporting, deposition, and trial, including appearing on camera.

The answers to these questions will help the hiring manager select the very best expert consultant for the project.

Founded in 1985, The CECON Group specializes in providing science and engineering consultants and expert witnesses. Consultants in our global network typically have more than 25 years of experience in more than 200 disciplines, including pharmaceutical development and regulatory compliance, chemical processing and safety, biotechnology, medical devices, nanotechnology, and polymers and coatings.

For details, visit www.cecon.com or call 888-263-8000.

April 16, 2014

How One Pharmaceutical Manufacturer Cut Costs while Enhancing Quality, Simplifying Processes and Streamlining Inventories

In part two of our series on cost control strategies for pharmaceuticals,  CECON consultant 1569, specializing in the formulation, manufacturing,  packaging, and dosage development of pharmaceuticals, walks us through a personal experience where he was able to lead a pharmaceutical company to realize significant cost savings.


It has been my experience that reticence to change is one of the primary reasons that pharmaceutical companies do not actively pursue cost savings as a means of improving their profitability. It is presumed that little or nothing can be changed, so why bother looking?  Other common deterrents to pursuing cost controls:

1.      “We have a Purchasing department that is responsible for obtaining the best pricing on all goods and services.”

2.      “R&D and Operations, and Facilities know what they want, so who are we (Purchasing) to question their judgment?”

3.      “Cost control is not really a viable means of positively impacting the bottom line over the long haul.”   

For pharmaceutical manufacturers, it is true that approved raw materials and components, validated processes and methods, and qualified equipment and facilities cannot be changed without significant cost and effort. Yet it is frequently (and mistakenly) assumed that these constitute all of a company’s expenses or that they cannot be modified in some way that can result in significant savings. Let me share an experience to demonstrate the fallacy that little can be changed in a regulated industry that might positively impact a company’s profitability.

A few years ago, I was retained to assess a stem cell manufacturer’s warehousing operations to see what steps could be taken to consolidate and manage their on-hand inventories to accommodate relocation to a new facility.  The new facility’s warehouse was only 3,000 ft2—about one tenth the size of the current warehouse—a challenging proposition to support expanded operations.

The first order of business was to evaluate all of the items inventoried in the warehouse and to understand why they were maintained at their current levels. Surprisingly, the company routinely kept on-hand unique inventory items. To name just a few:

1.      15-20 pallets of sterile, disposable coveralls, in 8 unique sizes (Small to 5XL). These consisted of cases of 25 coveralls per case. Provided with Certificates of Conformance.
2.      Several pallets of 3% hydrogen peroxide, USP. These were cases of 16 ounce bottles. Provided with Certificates of Analysis.

3.      Several pallets of 70% isopropyl alcohol, USP.  These were cases of 1 litre (=33.8 ounce) bottles.  Provided with Certificates of Analysis.

4.      Several pallets of dry ice delivered on a once/week basis.

The R&D group and Operations provided Purchasing with specifications and consumption rates on each of these materials and Purchasing took this information and negotiated supplier contracts to obtain the supplies at volume discounts.

In my assessment of on-hand inventories, I was not concerned about the suitability of these items for their intended use or their estimated rates of usage; but I was very concerned with minimum inventory levels, turn rates, expiry dating, etc. This exercise led me to ask: Are there better supply configurations for each of these materials that would require less space?  I was surprised to learn:

1.      The average cost of one sterile, disposable coverall was approximately $20.00. Personnel routinely wore two sets of coveralls per day.

2.      The cost of a case of six (6) x 16 ounce bottles of 3% hydrogen peroxide, USP was about $240.00 (three (3) x 32 ounce bottles of 3% hydrogen peroxide, USP at Target has a total cost of $2.67). That was one expensive Certificate of Analysis!

3.      The cost of a 1 liter (=33.8 ounce) bottle of 70% isopropyl alcohol, USP was about $90.00 (a 32 ounce bottle of 70% isopropyl alcohol at Target is $1.97).

4.      The company ordered over 5,000 lbs of dry ice pellets / week for storage, pack-out and shipping of their products. The reason they needed so much was because over 50% of it evaporated prior to its use.

Based upon this preliminary analysis, it became obvious to me that in addition to “right sizing” the company’s on-hand inventory for the new site, there were real opportunities for significant cost savings too. In assessing other supply configurations, it was learned that:

1.      With respect to sterile gowning, a local supplier of sterile surgical gowning was contacted and could provide two sets of washable, re-usable sterile gowns on a daily-basis at a cost of about $10.00 / per operator. This was a savings of almost 75%. The vendor’s quality systems were audited and found to be compliant and the vendor provided a certificate of cleanliness and sterility for all of its gowns.

2.      The supplier of hydrogen peroxide could provide cases of 4 x 1 gallon bottles of 3% hydrogen peroxide, USP (with a Certificate of Analysis) for about $600 / case. The cost for this same quantity (= 512 ounces total) of hydrogen peroxide provided in cases of 6 x 16 ounce bottles per case was $1,280. A savings of $680 per 4 x 1 gallon case configuration.

3.      The supplier could provide larger quantities of 70% Isopropyl alcohol, USP. A 4 liter bottle was available at about $200 (a savings of $160 vs. 4 x 1 liter bottles), or a 20 liter bottle at about $550 / bottle (a savings of $1,250 vs. 20 x 1 liter bottles), or a 200 liter drum at $2,500 (a savings of $15,500 vs. 200 x 1 liter bottles).

4.      As a large consumer of dry ice, the company investigated installing a dry ice on-demand manufacturing system within its new facility. A calculated Return on Investment of less than two years, made this an attractive undertaking.

These and other similar cost savings valued at a total of approximately $700,000 per year were identified during transfer of the company’s warehousing operations into the new facility. Although finding savings was not the primary objective of the assignment, it turned out to be an important benefit. The company’s Chief Financial Officer was ecstatic as these savings went right to the bottom line. While I was not aware of the company’s profit margin, I estimated it was between 20 and 30%. If true, these savings would equate to an increase in sales of $2.33 to $3.5 million dollars per year, each and every year.

Most noteworthy was the fact that in not one instance was it necessary to change a quality specification, re-validate a process or method, or re-qualify a piece of processing equipment. On the contrary, quality was enhanced, processes were simplified, and inventories were streamlined and optimized.

While this is but one example of a pharmaceutical company where significant savings were found, this is not the lone instance where I have found similar situations within pharmaceutical companies or other FDA-regulated organizations. It has been my experience that NOT finding comparable opportunities is more the exception than the rule. Yet these savings often go unrecognized.

Since 1985, The CECON Group has been placing experts in over 200 scientific disciplines. CECON consultants include pharmaceutical consultants, clinical trials experts, and chemistry experts.

April 10, 2014

Eight Agricultural Technology Solutions to World Hunger

The UN estimates that there are 86 food deficit nations, 35 nations currently in a food crisis, and 26 water deficient countries. About 39% of our world’s population is not served by any electric grid and 25% are without basic emergency power. Christianity Today reported 25,000 people were estimated to starve to death daily in a November 2008 article on world hunger.

One root cause, according to CECON Consultant # 1959, a power plant and infrastructure development expert, is that the agriculture that once produced food for direct human consumption has been industrialized and monopolized globally to now produce animal feed, luxury export crops, and global investment commodities out of both reach and benefit to the poor consumer and the small organic farmer alike. Even record yields don’t feed those who can’t afford their price. And the UN reports 41.5% of the world’s people have $2/day or less in spendable income, who are then squeezed out of the market to buy a subsistence plot of land for their survival.

CECON Consultant # 1959 is currently working on technologies in low-cost systems for greenhouse farming and community electric power plants. He proposes eight solutions for dealing with food and energy crises.

1. Build integrated electric power and greenhouse farming systems for serving communities and their surrounding small land holders, a specialty of CECON Consultant # 1959.

2. Construct single community electric power plants based on the site’s capabilities, free and waste fuels, and the project objectives and budget.   

3. Establish community-supported agriculture (CSA) in which the people of a community or village pay farmers (usually organic growers using native seed) in advance or by contract for food they pick up from them weekly during the entire growing season.

4. Enable the community or village to purchase local land for a greenhouse farm with additional plots if desired for lease or rental of equal shares to local consumers and growers.

5. Get prospective local small growers together to jointly purchase an agricultural tract, splitting its ownership at closing and possibly retaining equal shares ownership on some common ground for a greenhouse farm.

6. Pressure politicians to stop any cash subsidies to all farms over 20 acres in size, and focus on subsidizing say a 10-acre plot/family for down-payments and/or producing strategic crops for local direct human consumption. Class action law suits might speed up this particular solution as well as others.

7. Pass a family homesteading law to distribute a percentage (say 25%) of all federal and state owned conservation lands (such as Forest Service & BLM land in the US) to be completed in say a 2 year time maximum.

8. Require mandatory redistribution of all corporate farm holdings of 100 acres or larger in 10-acre parcels/family within 1 year. Similarly, Franklin D. Roosevelt required that insurance companies dispose of their acquired agricultural lands quickly in the period just following the great depression of the 1930s.

Experts report that producing the world’s human food requirements will use an amazingly small amount of land if greenhouse farming methods like theirs are applied. Based on their one-acre planned food & energy demonstration model, a 9,486 square mile area irrigated in greenhouse farming under moderately intensive organic farm management will provide adequate fish, fruit, & vegetable protein and nutrition for 6.5 billion people. That area would occupy a square plot 97.4 miles on a side, being 16.86% of the state of Iowa’s size, or 1.4% of the United State’s cropland area of 420 million acres. This area would equal seven global square plots measuring 36.81 miles on a side.

Consultant # 1959 also says that the free fuels of hydroelectric power, solar thermal, and waste utilization can provide the world’s grid-less areas with very affordable electric power without the requiring high tech solutions and equipment.  2,366.4 square miles of land (a square 48.65 miles on a side) could produce 3.029 billion gallons of ethanol transportation fuel per year for 302.9 billion transportation miles using a modern steam car version of the Stanley Steamer automobile (1897-1924). Allard Research & Development is working on a 100 gal/hour community ethanol plant that could pay for itself in less than two years at a capital investment of $150,000 (US).

 The challenge is to implement these solutions and safeguards to our freedoms from underneath the special interest alliances already in place. Dr. Vallianatos, in his book This Land is Their Land, reports these hidden self-serving corrupt alliances of land grant agricultural universities, federal governmental agencies, and their big corporate (sometimes multinational) supporters. If the present trend continues unchecked, it is possible that two dozen companies could control most of the planet’s food and energy resources very soon. 

Some individuals are undoubtedly already thinking about how to legally implement technology and equipment exchanges discreetly to secure their families and communities or villages.

 Note: The opinions contained in this article are those of the author, 
CECON Consultant # 1959, and do not reflect an official position of The CECON Group.

The ingenuity, hands-on experience, and technical expertise of its consultants is what keeps CECON thriving. Since 1985, The CECON Group has been placing experts in over 200 scientific disciplines. CECON consultants include Agricultural technology consultants, energy experts, bio-technology consultants, food science  consultants, and engineering experts. 

April 8, 2014

5 Reasons Pharmaceutical Companies are Missing out on Significant Cost Savings—Cost Control Strategies for Pharma Part 1

Many pharmaceutical companies look at cost controls as a means of bolstering their bottom line in the face of increasing competition and external pressures to reduce the price of medications. Yet many struggle to identify and implement significant savings. CECON consultant 1569, specializing in the formulation, manufacturing,  packaging, and dosage development of pharmaceuticals , lays out the top five reasons why.  Next week, in Part 2 of this series, we’ll provide a personal example of leading a pharma company to significant cost savings.

1.      Reluctance to make changes that might create risk

Pharmaceuticals is a highly regulated industry that requires companies to use approved grades of raw materials and components in processes which must be validated and employ qualified equipment systems and facilities. Additionally, raw materials, components, intermediates, and finished products must be analyzed and released using sophisticated, qualified instrumentation and validated methods. It takes years and millions of dollars to conduct the studies necessary to establish these levels of control before a company is authorized to sell a product. Consequently, companies are reluctant to make changes that might risk the quality and commercial availability of their products.

2.      Executive management does not appreciate the potential cost savings within their organizations, and as a consequence, has not made cost control a major business objective of the entire organization.

From the board room to the mail room, commitment to a comprehensive cost control program has to be communicated to and embraced by all employees. Management has to make cost control not only a business objective, but also every employee’s personal performance objective. Each employee should have a job performance objective of actively participating in the company’s cost control program. Companies should seriously consider rewarding employees with a portion of the savings they identify and implement.

3.      Companies do not have the proper structure in place to identify and implement significant cost savings.
Because of the vast number of regulations governing pharmaceutical products as well as the inherent complexity in these products’ development and production, it is not realistic to assume that one department (let alone one person as is the case in many companies) can effectively evaluate and implement significant cost savings. An effective cost control program must be a team effort and the team must minimally consist of personnel from R&D, Engineering (Process and Facilities), Operations, Quality, Purchasing, and Regulatory Affairs. These individuals should be cross-trained in basic skills such as Current Good Manufacturing Practices (21 CFR Parts 210 & 211), ICH Quality Risk Management, basic accounting principles, and Return On Investment (ROI) principles. Management needs to empower the team in its work and stand-up for the team when it questions and evaluates a company’s “sacred cows” for potential slaughter.

4.      Comprehensive data needs to be collected, maintained, and analyzed with respect to a company’s costs.
To perform an effective evaluation of the best opportunities for cost savings and their potential impact; comprehensive data needs to collected, maintained, and analyzed. In many organizations where I see great opportunities for cost savings, I also see poor documentation and accounting practices. Frequently, expenditures are mis-categorized and as a result, the spending habits and patterns of the organization are not truly known.  

5.      Like quality, cost, needs to be a characteristic designed into a product

Because of regulatory constraints, and the inherent expense in both time and money, to make changes to approved products; cost must be a design consideration in the development of new products. Companies should evaluate the potential benefit to added product features relative to their cost and ultimately the impact to the profitability of the organization.

There’s no question that there are inherent challenges to identify and implement significant cost savings in pharmaceuticals companies. However, these challenges are not insurmountable. Companies that make a commitment to cost control, set-up the cross-functional teams needed to identify, assess, and implement them, and consider cost in the design of their products can realize significant savings. In my next article, I will offer an example of a pharmaceutical company who cut costs while improving quality.

Since 1985, The CECON Group has been placing experts in over 200 scientific disciplines. CECON consultants include pharmaceutical consultants, clinical trials experts, and chemistry experts.

April 3, 2014

Nanotechnology Innovation Offers Hope that Diabetics can Skip Injections

Patients diagnosed with Diabetes 1 and advanced cases of Diabetes 2 often have to give themselves painful insulin injections – sometimes as many as several per day.  Researchers at UNC-Chapel Hill and NC State have developed a nanotechnology platform that may enable diabetics to have their insulin delivered painlessly via a handheld ultrasound device that would release nanoparticles infused with the essential hormone.

The nanoparticles used in the study are made of poly(lactic-co-glycolic) acid (PLGA). They were coated with alginate and chitosan which have negative and positive charges so that they would form a “nano-network” through which the insulin’s release could be controlled. In studies done on mice, the nanotechnology networks were administered subcutaneously and then activated through focused ultrasound, providing insulin for up to ten days and eliminating the need for days’ worth of injections.

Nanotechnology innovations have been found to be effective in the treatment of a number of difficult diseases and recently received a lot of attention when UCLA’s Jonsson Comprehensive Cancer Center used them in the treatment of pancreatic cancer.  In the UCLA application, two different nanotechnology particles were used: one created a path to the cancer while the other followed and delivered a reservoir of chemotherapeutic medication. The treatment was devised by Andre Nel, a UCLA nanomedicine professor and Huan Meng, an adjunct assistant professor.

The Food and Drug Administration, as well as many of their European equivalents, have approved a variety of drug delivery approaches using PLGA.  The use of the copolymer is particularly attractive because it degrades so easily. When it breaks down it produces lactic acid and glycolic acid, two monomers that the body is accustomed to processing and which have minimal toxicity.  Other studies into the use of nanotechnology are focused on the delivery of vaccines and even for non-invasive imaging techniques.

Since 1985, The CECON Group has been placing experts in over 200 scientific disciplines. CECON Consultants include Nanotechnology Experts,  FDA ConsultantsPharmaceutical Consultants, Experts in biotechnology and  medical devices,, and Polymers & Coatings Experts

March 27, 2014

Researchers Use Opal Structure to Improve Thin Film Solar Cell Efficiency

A new approach to solar cell design is raising hopes for lower cost electricity derived from solar energy.  Researchers from Purdue University’s School of Electrical and Computer Engineering and Birck Nanotechnology Center have devised a 3-D synthetic crystal that absorbs, retains and utilizes sunlight more effectively than traditional thin-film cells

Conventional solar cells are made of single crystal silicon wafers, but those made of thin-film silicon cells are 100 times less expensive. Unfortunately, the thin-film cells’ material and structure allows sunlight to enter and then quickly reflected back out of the cell, making them much less efficient.  Perdue researchers have found that by introducing synthetic crystals with an “inverse opal structure” into the construction of the thin-film cells, that once sunlight enters the cell it is diffracted and the opal structure traps light for longer periods of time, increasing the probability of converting the solar power to electrical energy.   

According to Peter Bermel, an assistant professor participating in the study, the goal of the research was to determine whether introducing the 3-D photonic crystals into crystalline silicon solar cells would make them more efficient while maintaining their lower cost. “The question is, can we make up that lower efficiency by introducing new approaches to light trapping for thin film solar cells? Can we combine low cost and high performance?”

The study showed that the opal structure increases the thin-film cells’ efficiency and absorption of near-infrared light by approximately 10%, and that with more research greater efficiency may be gained.

Though solar cells were originally designed to be made of thick single crystal silicon wafers, the cost was prohibitive for widespread use, so the multicrystalline and thin-film silicon solar cells have gained in popularity. Unfortunately, their efficiency in absorbing near-infrared light is not optimal. According to Bermel, “Light in the near-infrared range is important because there is a lot of solar energy in that wavelength range and also because silicon can convert near infrared light to energy if it can absorb it, but thin films don’t fully absorb it.”

In order to increase the thin film’s ability to absorb light, the researchers used a process known as meniscus-driven self-assembly to create a synthetic opal structure that is made up of hollow spheres of air that are encased in silicon. Much like natural opals, which diffract different wavelengths of light at different angles, the synthetic opal structure bounces the near-infrared light around internally, lengthening the solar cell’s access to the energy from the light.

Since 1985, The CECON Group has been placing experts in over 200 scientific disciplines. CECON Consultants include energy experts, renewable energy consultantsengineering  experts,  and films and coatings experts.

March 24, 2014

Yoga Mat Chemical in Bread: Is it really hazardous? CECON Chemist comments on the toxicity of ADA.

Several weeks ago, concern was raised by environmental groups about a chemical called  Azodicarbonamide, (ADA) a chemical foaming agent that is used in some plastics (like yoga mats) being a common additive in commercially prepared bread. ADA added to bread flour shortens the processing time for commercial bakers by making the dough rise more quickly.

We asked Dr. Stanley Tocker, a chemist with The CECON Group, what he thought of the toxicity of this chemical.

Dr. Tocker reported that this chemical has not been widely tested, but he did not see any supported data on toxicity. While there is lots of chatter about the dangers of this chemical, it appears to be safe at the concentrations (40-50 parts per billion) in commercial products.

According to Dr. Tocker, when ADA is cooked, it breaks down, leaving behind miniscule residues of nitrogen, carbon monoxide, ammonia, and carbon dioxide. Such levels of these chemicals have not been found to be harmful to humans.

So, for now, until solid evidence is presented, you don’t need to worry when eating your sandwich rolls in restaurants!

Dr. Stanley Tocker, Executive Vice President of The CECON Group received his Ph.D. in Organic Chemistry from Florida State University. Dr. Tocker has 40 years of experience in organic synthesis, polymers, pesticides, formulations, patent strategy and chemical products liability. He has served as a technical expert witness on many occasions.

March 21, 2014

Pharma Outsourcing Trends, Part 1: Why is Pharma Outsourcing on the Rise?

A question we hear at The CECON Group is “Why are pharmaceutical companies increasingly seeing the need to hire outside consultants?”

We approached Dr. Barry Bowen, CECON Vice President and Program Manager, a consultant with more than 35 years of experience in business leadership, human resources, and technical project management.  He offered his observations regarding the areas where companies are using outside consultants in the pharmaceutical industry.

Dr. Bowen has noticed the following trend in client needs:
  • ·       Temporary quality control management;
  • ·       Audit and reporting expertise;
  • ·       CRO/CMO selection and compliance/audit functions;
  • ·       New molecule research, including literature and lab work;
  • ·       Assistance with strategy for new molecule clinical studies for future FDA acceptance;
  • ·       FDA compliance of internal software and computer systems.

We asked Dr. Bowen what was driving these trends.
“These trends are partly due to pharma’s evolving business strategy to gain more growth and more profit from existing product portfolios, rather than high emphasis on filling the pipeline with potential winners.  This business model may mean purchasing more research, ingredients or products, all of which must be vetted and tracked for quality and compliance.  It may mean protecting intellectual property more vigorously or simply paying more attention to efficiencies of established internal systems. Engaging career pharma specialists, consultants, and expert witnesses for relatively short periods of time, can often be faster and better investments than waiting for new employees to mature.”

A long-time CECON pharmaceutical consultant and former FDA Science Branch Director has noticed another trend: Outsourcing of production of pharmaceuticals themselves.   He has observed: 
“Pharma production outsourcing occurs because it is cheaper than making it in-house. Labor rates are lower and companies avoid capital expenditures on new (brand new or replacement) equipment. However, firms are starting to see that they have a false economy. There are many cases of API (active pharmaceutical ingredient) contamination, and out-of-specification final products occurring.  This is because "you get what you pay for." Buy cheap and get cheap. Pharma executives are beginning to realize this.

Firms are finding out that foreign made products can be problematic.  FDA directed company recalls of finished products are occurring.  FDA 483s and Warning Letters are being issued. The challenge is to select a quality company when outsourcing, which can cost more and take more time.

My recommendation is that if you contract out, do it in the United States. It will cost more, but you can visit facilities and inspect them readily yourself, thereby avoiding problems.  I see that happening now, yet slowly; outsourcing continues, but it will be with domestic firms.”

In the March 3, 2014 issue of Chemical and Engineering News, a series of case studies is detailed in the article  “From the Lab to the Production Plant.”  The article’s author, Michael McCoy, notes that “Often innovation occurs at small entrepreneurial firms. Typically started by visionary men and women, these companies have great ideas and skilled scientists, but they rarely have the resources to make their molecules at large enough scale or with consistent enough manufacturing processes for use in clinical trials.” Production is then outsourced to contract manufacturers.

  Have you noticed any additional trends in outsourcing?

Founded in 1985, The CECON Group specializes in providing science and engineering consultants and expert witnesses. Consultants in their global network typically have more than 25 years of experience; CECON offers consultants in more than 200 disciplines, including pharmaceutical development and regulatory compliance, chemical processing and safety, biotechnology, medical devices, nanotechnology, and polymers and coatings.

For details, visit www.cecon.com or call 888-263-8000.