Howe's Law: Every man has a scheme that will not work.

Gordon's First Law: If a research project is not worth doing at all, it is not worth doing well.

First law of evolving system dynamics: Once you open a can of worms, the only way to re-can them is to use a larger can, giving you a bigger can of worms.

Ninety-Ninety Rule of Project Scheduling: The first 90% of the job takes 90% of the time, and the last 10% takes the other 90%.

The six phases of a project are:
1. Enthusiasm
2. Disillusionment
3. Panic
4. Search for the guilty
5. Punishment of the innocent
6. Praise and honors for the non-participants

Some people react to good or bad important news by going Mmmmmmmmmm, as if they already knew this or didn't care. This can be a useful technique to learn, or a ruse that you may want to challenge.

The concept of a product's medical value has to be carefully and creativiely built and developed. Medical value is not a simple concept and various ways of expressing this must be evaluated.

Agreements between a pharmaceutical company and an investigator have morphed over the last 35 years from being a gentlemen's agreement and a single page letter to a rigid contract geared to protecting the institution, preserving academic freedom and rights of the company.

Data from several small trials or even from case studies, can be combined in a meta-analysis to achieve a whole that is greater than the sum of its parts.

A clinical professional assigned to focus on patient retention in a clinical trial should be proactive and try to prevent issues that may lead to patient withdrawal.

One will make better decisions about a drug's development using high quality clinical data from fewer patients than by basing the decision on mediocre data from a large number of patients.

Challenge yourself and others to reduce the number of inclusion criteria, even for Phase 2 trials where you want a homogeneous population of patients.

While a statistical interpretation of clinical data is done by a statistician, the clinical interpretation of clinical data is done by a clinician. Even if a single person is trained and experienced in both fields the two processes are different.

Analyses of clinical data usually refer to statistical analyses. A clinician is important for making suggestions (to a statistician) of which analyses to conduct, both in advance of the trial being completed and after the initial analyses are completed.

Unexpected or strange interpretations should always be carefully assessed, questioned, and reassessed before they are either accepted or challenged.

One can improve the value of a product by focusing attention on how you refer to the product you are developing. The first point is to try and find another term than "drug" to describe the product. A few of the many alternative terms are: enzyme replacement, antidote, chemopreparative regimen, essential nutrient. Note that an enzyme replacement does not have to be an enzyme. The connotations of the chosen term may facilitate interactions with regulatory agencies and eventual marketing.

The closer that community based trials can approach the actual practice of medicine, the more willing practicing phsicians will be to accept the results of the trials and apply them to their own patients.

Active drug surveillance techniques can preempt accusations by a vocal consumer activist group that a company is not acting responsibly to investigate and study an issue or problem with one of its drugs.

If more than three people have to approve routine drug development proposals the company has an important issue to investigate as it is not being efficient.

However beautiful the strategy, you should occasionally look at the results.
Winston Churchill, British stateman and author
However beautiful the mechanism of action, you should occasionally look at the evidence that supports it.
Bert Spilker, author and consultant

Nothing is impossible. Some things are just less likely than others.
Jonathan Winters, comedian and author

Emperor's Advocates are people who tell the Emperor that his last comment has made the bullshit detector go off the scale.

Have you ever noticed that most people's sense of humor improves as they rise on the corporate, government or academic ladder. This is usually a function of those who report to them wanting to please and appreciate their boss's attempts at humor.

Perform all activities as if they are the only things that matter.

Pharmacokinetic, quality of life and pharmacoeconomic studies can be designed as add-on or as free standing clinical studies.

Golden rules help a company decide where they are in terms of standards and where they want to be. Golden rules also provide a path to help guide changes toward the goals.

Consider the degree of extrapolatability of every clinical trial and every pre-clinical experiment designed. For example, it is generally desirable to use strict inclusion criteria in Phase 2 to obtain a fairly homogeneous and narrow patient population, whereas in Phase 3 it is usually the opposite. Thus, large Phase 3 trials include patients with other diseases, other drugs and other types of medical status to enable the sponsor to be able to extrapolate the data to a greater proportion of the entire patient population to be treated.

Zero based inclusion criteria means that each protocol starts with a tabular rosa. Only those criteria that are essential are added. Each criterion is kept as broad and least restrictive as necessary (e.g.,age limits).

Truly great scientists do not generally make good managers. Creative scientists must be encouraged, stimulated and rewarded so that they are happy to remain creative scientists.

Good managers do not generally make good leaders. Good leaders will have charisma, charm and qualities that encourage people to follow them. Good managers have other traits that get things done efficiently and on-time and on-budget.

The regulatory cascade consists of laws that lead to regulations, which lead to guidelines, which lead to points to consider, which lead to formal recommendations, which lead to podium policy, which lead to informal comments, and which finally lead to gossip.

Harmonizing regulations at ICH prospectively before any regulations exist is a lot easier and more efficient than attempting to harmonize them retrospectively, where three different sets of regulations exist and have to be harmonized into a single whole.

When you are asked for a date when you can complete an assignment, always ask: "When is it needed?"

Without pharmaceutical, biotech and genetic research, mankind has little hope of major advances in treating disease, but public support for clinical research is a mile wide and an inch deep.

Exercise great caution in hiring academic or government executives into the industry as you may have to spend years of "on the job training" to have them reach the state that many industrial managers are at today. Many acacdemic and government executives, managers and scientists never adapt adequately in industry, and a company takes a great risk in hiring these professionals, regardless of their experience and intentions.

Always maintain a sense of urgency in your work, and be cautious if you are told that you can "take it easy."

Remember that when a person is doing X they are not doing Y and when a person is doing X and Y they are not doing Z. The same principle holds for a company.

Accept responsibility for your actions and errors and do not make excuses or become defensive. Rather than saying "it's not my fault" seek a solution that helps everyone.

Always share information with those who "need to know." If the information is sensitive do not sent it to those for whom it is "nice to know." If the information is not sensitive, be more open to sharing it with the latter group.

Some staff are loaded with work like a donkey, and more and more is piled on their backs. However, peaks and valleys of both work and stress make for healthier workers than a constant series of high peaks and continually higher plateaus.

Market forecasters cannot win. The best they can hope for is to place or show.

The most important challenges of your job may not be the ones you think they are.

Limit staff time spent on trade or professional association activities. It should rarely be allowed to exceed 10% of a person's job, unless it is their job.

A portfolio of projects should balance those of high, moderate and low risk, but this does not mean in equal numbers. The best balance will differ among companies and depends in large part on resources, executive personalities in terms of risk averse versus risk loving, and opportunities.

When dealing with regulatory agencies and the public it is always best to try not to bury issues or problems, but to be transparent and to discuss how you intend to deal with them and how you will keep them informed.

Anyone entering a crisis situation should remember the lessons from the Tylenol poisoning experience: be open, honest, and sincere.

Don't tell someone to do something ASAP without providing a specific deadline as some will interpret this request as "do it by next month" and others as "do it tonight, even all night if needed" and it may only be required in a week.

Learn the many ways to avoid playing "telephone tag," as that is a wasteful and frustrating game. For example, set a time for a call with the secretary or person involved by an email or fax, or put a proposal in writing if it is possible to avoid a call altogether.

Develop and implement patent-extension strategies as soon as an NDA/BLA is approved, if not before.

Working hard to build and maintain a strong and positive relationship with each regulatory group and division you work with will pay important dividends.

Pharmacodynamics is what the drug does to the body after reaching the receptors, and pharmacokinetics is what the body does to the drug.

Good ethics may be defined by answering two questions: Would I do this for my children and how would I feel if this is put on the front page of the nation's top newspapers?

Good ethical standards motivates staff, builds morale and promotes sleep.

"If everybody is thinking alike, then somebody isn't thinking." George S. Patton,Jr. US WWII general

"Wisdom consists not so much in knowing what to do in the ultimate as knowing what to do next." Herbert Hoover, 33rd US President

Using visual models of drug development enables one to conceptualize the strategy for development and to determine if new proposals fit the model or are tangents.

Steps to shorten the time for drug development are usually under the company's control moreso than that of the regulatory agencies, particularly in terms of further gains to shorten this period

Asking the reight question is the single most important aspect of conducting successful research. It is the starting point of the experimental process. Never start to answer the question until you are certain that it is the best one and is phrased as well as possible.

Golden rules of drug development (and of each of the components of drug development) are not only principles and standards to use, but include the best practices, and also represent goals to achieve.

The primary goal of regulatory agencies is not to approve new products but to ensure that existing products and any new ones will help the public while minimizing any harm to patients.

Utilizing operations manuals in clinical trials facilitates the ability of the staff to answer their own questions and to perform a trial more efficiently.

Internal benchmarking tracks activities and is extremely important to measure and assess progress toward one's goals. External benchmarking is generally a case of chasing the other guy's tail. If external benchmark data can be validated then those data will also have great value and may influence decisions.

Success is based on achieving many small goals, and castles are built one stone at a time. Of course having 1000 competent workmen on a project does not hurt, especially if they are working with a sense of urgency under competent supervisors and with a well planned blueprint.

At the start of a project, planning is 100% of the work, but when one is implementing the plan and doing the work it rapidly consumes less time, as long as the plan is reviewed to ensure it remains viable, and the work being done is appropriately monitored.

Some staff never seem to wait for required information and data before making decisions and initiating actions. It is essential to identfiy these people and to speak with them about jumping too soon. Of course the opposite extreme is also a major issue or problem.

Work hard to avoid clinical trial protocol amendments as they consume a great deal more resource than one imagines in staff time to prepare, review (internally and by IRBs and FDA and sometimes by the investigators), and implementation. Some vendors offer systems to minimize the number of amendments a company will need by subjecting protocols to multiple internal checks of consistency and comparisons with other protocols that have been conducted.

Mega trials require shorter protocols, shorter case report forms and less monitoring. Companies often monitor these (and other) trials more than needed.

Reimbursing for patient travel, babysitting, meals, parking or transportation and other incidentals is acceptable in most, but not all, countries for all patients in clinical trials.

Double blinding a clinical trial (i.e., the investigator and patient) is rarely sufficient today to maintain a sufficient blind. It is also necessary in most cases of randomized controlled trials to blind the clinical monitors, the sponsor's statisticians (except for one), and the staff who are conducting special procedures (e.g., EKGs, eye exams, MRIs).

Single-blind trials are virtually equivalent to open-label trials.

Double-blind trials vary along an entire spectrum from those that are truly double- blind to those that have become totally un-blinded. It is often imprtant to determine where on that spectrum a specific trial is located. This can often be determined by questioning the investigator and patients about the treatment they believe was given and the reasons for their choice. Surprises often occur in reviewing these data.

Open-label clinical trials often mislead a company as the data obtained have a much greater likelihood of being positive than if the same trial was done in a double- blind manner. This may lead to a company wasting years of effort and millions of their money until they recognize that the drug really did not demonstrate efficay in a true double-blind study.

About 80% of open-label trials are positive whereas only 20% of double-blind trials show positive results when the exact same question is evaluated in an almost identical study.

The ability to pose the most clear, most focused and appropriate research, marketing, business or other questions to address is an extremely valuable skill for everyone to develop. Those who can do this well should become known within and outside their organization for this skill, and their advice and input sought.

Professional talks and presentations are not like mystery novels where you build to a glorious and possibly surprise climax and conclusion. Share the conclusions up front with your audience or listeners. Tell them what you will tell them, then tell them, and then tell them what you told them.

Learn what it means to service your customers. Everyone without exception has customers (even the Chairman of the Board), so identify all of them and then listen carefully to them.

For those who use consultants, even on an occasional basis, identify a group of core consultants in each area and function where you may need their assistance.

There are two major ways used to discuss the overall costs of bringing a new drug to the market. First, the cost of all failures and all successes over a period of time are totalled, averaged and then presented as the cost of a single success. The other approach is to solely determine the discovery, development and other costs of only one specific drug that is brought to the market. Both ways are important to understand as each has its own specific and legitimate uses.

When words like "compliance" and "risk" are used, does everyone reading the text or listening to the presentation understand which definition is being used? These and many other words have a variety of definitions, particularly for those with different perspectives and positions.

According to regulations, new drugs do not have to be better than currently marketed drugs in their degree of safety or efficacy. However, some regulators forget this and have to be reminded. If safety or efficacy is not quite as good as a marketed drug the other component must greatly exceed current therapy for the benefit to risk ratio to be positive in comparison to currently approved therapy.

We have GCPs, GLPs, GMPs and others. We theoretically have GRRPs (Good Regulatory Review Practices)but the industry and public need to know that they are published and are being followed. How about an annual audit system conducted by GAO--and a comparable group in other countries?

Why is it that the systems for appealing the FDA's decisions and those of other regulatory agencies are so limited and fraught with repercussions? More oversight and accountability for the quality and rationality of their decisions is needed.

Ensure that at the end of every regulatory agency meeting the company summarizes all points of agreement and all action points for each side to conduct. If the agency makes this summary, ensure that it is complete and that all of their statements are acceptable.

Provide a copy of the company's minutes of every regulatory meeting to the agency within one week to assist them in preparing their own minutes, and to ensure that they have considered all of the points you have made.

There is an art to slide management in terms of design and content, and in the indexing of slides in complex and/or long presentations, particularly when backup slides need to be called up virtually instantly (e.g., at FDA Advisory Committee Meetings).

The golden rule about inclusion criteria for clinical trials is to use the minimum number necessary and with the least restrictive ranges possible. Start every protocol without any inclusion criteria, even if 50 trials have previously been done on the product and determine which ones are essential. Each one restricts the potential available pool of patients you can enroll.

Using minimally acceptable criteria for continuing with a product's development facilitates the best business decisions and helps to avoid games being played on prematurely terminating a viable project or prolonging a dying or even dead project.

I have not failed. I've just found 10,000 ways that won't work. Thomas Edison.

In the field of observation, chance favors only the prepared mind. Louis Pasteur

An investigator who is not enthusiastic at the outset of a project will almost never be enthusiastic at the end of it.

If your company's staff are not 100% excellent, decide how you can attract and retain better staff.

Are the company's managers mainly living in the past, present or future? How many are in the present and keeping an eye on the future while planning how to get there? Where are you living?

TOP TEN RISKS FOR CLINICAL TRIALS

The top ten risks will vary in each trial based on many factors, so that a composite list for all trials cannot be accurate. This list also reflects the author’s views and experience, which will not mesh completely with those of each of his readers.

These risks are presented in reverse order of importance.

10. Too many patient visits are scheduled and/or too much time and effort of
patients are required at some or all visits
9. Outsourcing to CROs and vendors is not done correctly or efficiently (e.g., CROs
are not carefully monitored, communication plans among all groups in a trial are
incomplete or inefficient)
8. The patient retention strategy is inadequate, so that too many patients leave
the study and follow-up for important data from those who drop out or are
discontinued is not adequately planned in advance
7. The trial is stopped too early after an interim analysis and the data are
inadequate to convince regulators and/or practicing physicians about the
product’s safety or efficacy
6. Too many procedures and/or tests are conducted at some or all patient visits.
This often results from simply adding new procedures and/or tests to the last
protocol performed with the agent
5. The primary trial objectives either represent a baby step forward from the
previous trial or too great a giant step from the previous trial (i.e., the
primary objectives may not be the best ones to choose)
4. The investigators chosen to conduct the trial are not the most appropriate ones
for any of dozens of important reasons, including lack of adequate due diligence
3. The trial design chosen to address the objectives is not the most appropriate
nor efficient one
2. The inclusion/exclusion criteria are too restrictive and have limited the
potential population more than is necessary
1. The recruitment strategy is not adequate to obtain the necessary enrollment at
the necessary speed

To learn more about these and other risks refer to “Guide to Drug Development: A Comprehensive Review and Assessment” by Bert Spilker. Published by Lippincott, Williams and Wilkins (Philadelphia), 2009.

Find creative colleagues, both inside and outside your company or organization whom you can approach for informal or formal consults. Determine if any of these can or should be approached to possibly become your mentor, or simply a trusted peer.

Eliminate hidden agendas and company politics whenever possible, if they interfere with progress and efficient development. A direct way to approach this (when appropriate) is to speak with (or remove) major perpetrators. An indirect way is to discuss this issue with their supervisors, those who lead meetings or projects where this occurs.

Try to present a range of possible options for discussing an issue or problem with others instead of strong recommendations.

Some workers want to only present a highly polished work product, rather than a rough plan, outline or partially completed work so that others can provide input. It usually is preferable to complete work products in an iterative manner so that you have buy-in from the necessary people.

While large and many medium size pharmaceutical corporations go through periods of divesting businesses and acquiring new businesses, they should always try to avoid being dependent on only one or a few products.

All companies (including virtual companies) need both leaders and managers. Each employee or advisor should know their roles, and leaders should not act as managers and vice versa.

International pharmaceutical companies may be managed using a structure/model that varies from a totally centralized one to one that is totally decentralized, where each part (e.g., based on the country, function or other factor) acts independently and seeks to coordinate with others when possible. A dual headquarters model is sometimes used (e.g., Europe and US).

Seek ways to create an environment and milieu that facilitates discovery, where imaginative scientists can communicate, create and flourish.

Managing discovery oriented scientists cannot be heavy handed using the same control mechanisms and systems that a company uses to move development projects and marketed products forward. Activities in development and marketing can be more tightly planned, controlled and reviewed than those involved in discovery.

Drug development comes with only one guarantee. The guarantee is that there will always be surprises.

When you cannot solve a complex problem easily or completely, divide it into pieces and address each of those separately. Almost all problems or issues can be divided into multiple components, each of which may be more easily resolved than a single large one.

A company must identify and align its vision, mission, objectives, goals, strategies and tactics. Just as a car needs periodic alignments and checkups, so will a company have to re-align these characteristics from time to time.

Every major function within a company should identify its own mission, objectives, goals, strategies and tactics, and ensure that they are aligned with those of the corporation. Smaller groups within each major function must do the same.

A company must know what it wants to be when it matures. Nothing is more frustrating to the staff than a company that flounders from one vision to another without the full support of its members. Major changes must be accompanied by a sound rationale and open discussions with and among the staff.

All professionals have conflicts of interest. The real issue is whether these will lead, or have led, to bias, and if this bias will affect the study design, conduct of the study, data analysis or interpretation of the data.

Seeking to find people without a conflict of interest is foolish. It is more critical to assess their degree of bias, based on past publications, speeches and other information. Even having a pet theory to support often leads to bias in viewing scientific proposals or publications from others.

Data analysis and interpretation of data are two separate processes, even if they are conducted 30 milliseconds apart by a single person. Data analysis and statistical interpretation, however, is usually conducted by a statistician and clinical data interpretation by a scientist or clinician.

A clinician is the only one to determine clinical significance, while a statistician determines statistical significance. Of course, a clinician who is trained in statistics can also conduct statistical analyses and interpretations.

Sunset clauses for all discovery projects are a useful means to ensure the company reviews progress on each project to confirm that it should be continued. These reviews may occur every two years or at other pre-assigned times.

Are your company's public statements being followied in practice? If not, try to reconcile the two or it is likely to negatively affect staff morale.

Using higher medical and scientific standards than required often trumps the competition, as they will be trying to take some shortcuts,or follow a traditional development pathway; and; the FDA and/or other regulatory agencies will observe your standards as being improvements, and will raise the bar for marketing approval. Your competitors will be required to use the same standards you have employed and thus be set back in their work.

To read without reflecting is like eating without digesting. Edmund Burke (UK politician)

Obstacles are those frightful things you see when you take your eyes off your goal. Henry Ford (founder, Ford Motor Co.)

The sign of a good intellect is the ability to keep two contradictory ideas or thoughts in your mind at the same time.

It makes no sense to leave potential problems outside your plans if they have a reasonable likelihood of occurring.

There is a wide spectrum for discovering new drugs and new uses for marketed drugs that ranges from purely rational to that of pure chance or serendipity.

There are three key levels to think about various issues and topics: the overall industry, the specific company and a specific drug or product.

In the past, time was generally viewed in drug development (particularly in large companies) as the single most precious resource you had to spend, but in recent years the importance of financial resources has become steadily more important, and often has become the most critical factor.

Excessive travel for workers and also managers is counterproductive and wasteful of a company's resources, not to mention the wear and tear on the person and their family. They are unavailable for various activities from signoffs to internal meetings. The true need for all travel must be carefully examined before being approved.

A leader who gets too far in front of his team will be marching by himself.

Many people on the frontiers of knowledge disappear from view.

Do not issue reports as final if they may need a longer gestation period and more thought or possibly more data. Documents that may be altered after review by Regulatory Agencies (e.g., some medical reports) may also be kept in draft form until approved.

Seek a balance between having too many projects where they slow each other's progress, and too few where a company risks its ability to survive with only a few projects that may or may not succeed and achieve the company's goals. A balance does not mean equal numbers.

Seek a balance between initiating too many high risk projects where you make assumptions of how a drug will behave, and being too conservative and avoiding most risks, by not wanting to make assumptions of how a drug will act.

The state-of-the-art is becoming so advanced in several technical areas that it is not the most appropriate standard to use for medical product development. For example, minute amounts of a drug may be measured in blood, but those levels are not needed or used to make clinical decisions and do not provide relevant safety data.

New drugs and other medical products are like one's children. One has to be very careful with their development until they are old enough to be independent and on their own. This usually occurs some time after the product reaches the market and firms up its safety and efficacy profiles.

Consider the pros and cons of a multinational clinical trial before it is agreed to. Three adequately powered uni-national trials are usually preferable to one large multinational trial.

The primary reason why clinical trials fail is because of problems with patient recruitment.

Ask yourself whose responsibility it is to create a strategy that will recruit patients for a sponsored clinical trial. If you said "the investigator" you are wrong. It is the sponsor's responsibility to create a strategy that will be successful, and if there are problems, it is the sponsor's role to learn the cause of the problem and to adjust the strategy to ensure it succeeds.

A Japanese "Go" master should be an expert in business because he will understand the balance of offensive and defensive moves and positions. All pharmaceutical decision makers should learn this game to help them improve their skills in balancing offensive and defensive moves in their business moves.

Changing research directions or policies without a compelling rationale confuses staff and my lose their loyalty and dedication.

Seek a balance between having too many projects that slow each other and too few where a company risks its ability to survive on a few projects that may or may not succeed and achieve the company's goals.

Empower all employees and managers as much as possible to make decisions they are capable and qualified to make. It builds morale, teamwork and ownership of the business, which facilitates success.

If it's not written down it doesn't exist.

Instead of discussing the elephant in the room at meetings, are people discussing what the fleas on the elephant ate for dinner last night.

When general words like research, development, compliance, risk etc. are discussed at meetings, does everyone know which definition is being used? Each of these have many different definitions and the specific definition must be clarified so that everyone understands how the word is being used.

When you are unsure about a topic, ask the basic questions: who, what, where, when, how, why and how much.

Those on the cutting edge of science often get cut.

Some people excel at planning and seem to spend all their time at it, and many of them are resistant to implementing their own plans. Planning should never take the place of doing or be an excuse not to Do. Remember that those who can DO, and those who can't, plan, plan, plan.

Try to conduct only those studies that are "Need to have" and not those that are "Nice to have," unless you have sufficient resources and no sense of urgency. Those without a sense of urgency should not be in the pharmaceutical industry.

Just because you will not see the work completed does not mean you are free not to take it up.

Many professionals in industry are gung-ho at the start of a project but lose interest as it progresses, so ensure the leaders of projects have staying-power.

Good judgment comes from experience, and experience comes from bad judgment.

Do not seek strategic clinical advice from academicians who believe they can become investigators on the trials they propose or endorse, because they have a serious conflict of interest.

The Executive Summary in a briefing package or other data/information sent to a regulatory agency must capture all of your key messages.

Using "common sense" to address or solve a problem may lead you off-track, because what is considered common sense in one country, and by one group of people, is not always considered as common sense in, or by, another.

The perception of a new product's medical value goes through a series of stages: from unrealistic optimism, to unrealistic pessimism, and eventually to a balanced view.

The army has a motto that there is never enough time to do it right, but there is always enough time to do it over. A company's motto must be: We must do it right the first time, and no excuses are accepted.

The drug development pipeline is not rigid, and is better viewed as a long flexible snake, which sometimes swallows a bowling ball, and at other times a ping pong ball. The efforts of the company and staff to pass a bowling ball through the snake will slow most of the other projects the snake has going through it.

Safety and efficacy standards can be viewed as a pair of high jumps for the product to exceed. As safer and more effective drugs reach the market, these bars become progressively raised.

Multinational clinical trials require many more resources and effort than a group of multisite uni-national trials. Is the juice worth the squeeze?

Accept your mistakes without being defensive.

The rule of meetings: From listening comes wisdom and from speaking repentence

When you know one division of FDA you know one division---and often not even that one

It's not sufficient to have SOPs in place. The company must ensure that their busy staff are following them, and that there is a system to keep SOPs up-to-date.

Never describe anecdotal information as data

Success is based less on brilliant ideas than on excellent execution of those ideas.

Avoid procedure bloat in a protocol. This occurs when a clinical trial protocol is prepared by taking the previous one for that product and adding some additional tests. This is fairly commonly done for drugs or biotech agents passing down the development path.

The impact of a statement equals its intrinsic value times the author or speaker's position in the organization to the 3rd power.

Some managers spend most of their time managing UP to their bosses, whereas others spend most of their time managing DOWN to their staff. Others spend their time with peers and ignore both up and down management. How do you balance your time as a manager? Just managing down with subordinates is not very good if you are beating down while you are sucking up.

January 14, 2009

Do your best to eliminate fads and hype in management styles and be skeptical of all claims by vendors and consultants

If you cut enough corners you eventually go around in circles

Harmonizing regulations at ICH should ideally be done prospectively, before any exist, as it is much easier than harmonizing them retrospectively, when three different sets of regulations have to be harmonized into a single whole

To win the hearts and minds of regulators one must establish the Medical Need for a new product (i.e., the Public Health message) and then establish the Medical Value of your product in terms of how well it addresses the Medical Need.

The Development Process begins the day the company agrees on a specific product (e.g., compound, device, agent) they will take to the clinic for testing.

The army has a motto that there is never enough time to do it right, but there is always enough time to do it over. A company's motto must be "We must do it right the first time."