______________________________Arrow-Pushing in Organic Chemistry: An Easy Approach to Understanding Reaction Mechanisms, 2nd Edition (111899132X) cover image

Sunday, April 22, 2012

Are there any jobs in Medicinal Chemistry? And how can I get one?

Through my efforts to provide encouraging information and strategies for those interested in life sciences careers, I will occationally invite guest bloggers to provide their thoughts.  My first guest blogger is Connie Hampton - founder of Hampton Associates and provider of scientific and executive search services.  Connie's blog is highlited in my blog list.  More information regarding her background and services can be found on her website (www.hamptonexecutivesearch.com).

Are there any jobs in Medicinal Chemistry? And how can I get one?

There are over 7,000 IPhone developer jobs today on SimplyHired.com and only 500 Medicinal Chemistry positions.  This is only 1/5 of the total jobs, but the other 4/5ths are filled before they are posted. Obviously it is much harder to get a job in Medicinal Chemistry than IPhone development.  These jobs are all over the world, from summer (unpaid) intern to Principal Scientist and Professor.  If you are one of the many students of medicinal chemistry about to graduate, how are you going to compete? 

Job Search is Tough and You were Never Taught How

Today’s economy is especially tough on small therapeutics companies.  Seed money is hard to find and further financing is even harder to get.  Since it takes 100 ideas and at least 10 years from proof-of-concept to marketed drug, the venture capitalists are putting their money into IPhone development in order to spend less than a year to get 4+ times their investment.   Medicinal chemistry is necessary in both large and small molecule drugs, but there are fewer companies and simply fewer positions than there used to be.

The solution to finding a job under these circumstances is to take on the task of finding a job as a job, to “hunt your own head” and become your own “job fairy”.
  1. Put in no fewer than 20 hours/week and preferably 30-40.
  2. Write, for your own use as a pool of phrases, what you bring to the table in the way of skills and cutting-edge knowledge
  3. Write your approximate overall career goal.
  4. Decide, geographically, where you want to work.  Will you move or will you commute?
  5. Start a database of all the companies within your commute distance which use the skills you have and can provide you with the next step in moving you closer to your goal.
  6. Start a database of the people you know, where they work and how to get in touch with them.
  7. Sync these two databases with each other.  Which companies do you already have a personal connection in?  Which do you need to get (at least) one?
  8. Start networking!  Up to 80% of jobs are filled by networking and only 20% by job boards
This is just the homework part of job search.  The next step is getting out there and meeting people to find out who has a problem you can solve.  Do you know how to network?

Networking is when you give something of value to the other person (that does not cost you much) and get something that you value (that doesn’t cost them much).  You give time, attention, information and you get time, attention and information. 

The first person you want to network with in a company that you are interested in should be someone who is NOT the hiring manager and NOT a person in the department that you want.  You need to know if the company is financially stable, a good place to work and fits with your idea of a good company.  Who of your connections is able to tell you these things?  You need to give them the gift of your attention.  Ask: “how do you like your job?”  and “what is it like to work there?” and “are they hiring or laying off?”

If the company sounds good, THEN you want to be introduced to someone in your preferred department.  You need to find out if they are working on any problems that you could help solve and present yourself as someone who could do so.  If they have a problem that is NOT one that you want to solve, then ask the same questions as above and move on.  But if they are working on something that appeals to you, have a very “geeky” conversation – ask really good questions, display your understanding of the issues.  At the end of the conversation, do NOT beg for a job. Do NOT hand them your resume.  Instead say, “What an interesting problem!  You must be having so much fun!” even if you know that it is not being fun for them. 
Then go home and put the person and company in your Gist.com database.  This site will sweep the internet for any mention of the person or company and look in Twitter, Facebook and blogs to find them.  This will allow you to email this person once a week with “saw this and thought of you” emails and therefore stay on the top of their minds.  When their boss and hiring manager realizes that the problem is not getting solved with the people he is already paying, the first thing he will ask is “Who do we know?”  Your name will be the one that comes up.

Stay in touch with your contacts in the departments of the companies you want to work for.

Keep checking their websites in case your job gets posted.

Stay alert to other ways that the company may be looking for you.

But keep on networking your way through the list of companies that hire people with your talents.

This is your career network and it will last you for the rest of your career.  You will help these people find jobs and they will help you.

Connie is a scientific and executive search consultant and a purple squirrel hunter – after a company has exhausted their network, posted the job and not found the right person, they turn to her to find that hard-to-find MD or PhD or MBA.

She started recruiting early in the history of the worldwide web.  While she does not restrict herself to just the web, she stays on the cutting edge of social media and makes full use of it in finding the right people for her clients.

Monday, April 2, 2012

Biotechnology and the Dot-Com Era

Earlier this month, I attended the CalBio2012 conference in San Francisco. Among the attendees were venture capitalists and executives from biotech and pharma companies around the world. The two days of panel discussions and keynote addresses focused on all aspects of these industries from financing strategies to reimbursement issues. As a networking event and major local conference, I found the topics highly relevant. However, of all the sessions, I found the lunch keynote speeches to be the most inspiring.

The keynote address on day one of the conference was particularly noteworthy. The speaker was John Crowley. To those of you who don't know, this is the man who risked his career to head up a company focused on finding a treatment for Pompe Disease – a terminal illness affecting his two children.

Pompe disease is a condition where glycogen is not cleared from cells. This leads to cell death, organ failure, paralysis and death. While the story of how the treatment was ultimately found and developed is truly an inspiring example of the hope and promise that biotechnology brings to this world, this story is not the focus of this post. For an excellent interpretation of the Pompe disease story, I highly recommend the Harrison Ford movie "Extraordinary Measure" which focuses on the Crowley family and their journey.

Instead of focusing on Pompe Disease, I thought it would be relevant, especially in today's economy, to comment on a small part of Crowley's speech describing previous attitudes towards investments in biotechnology. As you all know, investments in early stage biotechnology companies are considered highly risky. This is largely due to the roughly 15 year timeline from concept to market coupled with the 6% success rate for small molecule drug candidates completing clinical trials and becoming marketed therapeutic agents.

In the 1980s, VC financing and IPO interest in biotechnology companies were abundant. It seemed that any company incorporating the letters G, E and N in its name was likely to obtain needed funds. Examples include Genentech, Biogen, Genencor, Gensia, Amgen and many more. It will also be no surprise that all of these companies were running operating losses during their initial financing periods. Relevant to the Crowley keynote speech is his description of interactions he had with a venture capitalist while serving as CEO for a biotech company. Paraphrasing Crowley's narrative, the dialog went something like this:

VC: So, how are your sales?
Crowley: Well, we currently don't have any sales.
VC: I see. How strong are your revenues?
Crowley: Actually, we presently don't have any source of income.
VC: Interesting. When will your product be ready for market?
Crowley: Uncertain. There can be no guarantee that our product will ever be ready for market.

The above dialog summarizes the reality of the biotechnology industry from its inception to the present. The only driving force behind the ability to finance companies with long term operating losses and no guarantee of success was the hope and promise of a better future. For a long time, this was enough. Investors were interested and biotechnology was the only industry that could justifiably operate under this business model.

Let's now move ahead to the 1990s. In this period, a new industry emerged - the internet. With the evolution of the internet came may entrepreneurs eager to capitalize on the promise of e-commerce. Whether selling products or focusing on business-to-business services, investors were jumping into this new sector with hopes of making large profits and quick exits. While some of these dot-com companies had solid business models, most eventually came and went. That did not stop the massive ballooning of the IPO market. While some people did, in fact, realize significant returns on their investments, most did not. So, when the investing community had had enough, the dot-com bubble burst and the NASDAQ plummeted from its "irrationally exuberant" highs. Ultimately, much of this downturn rests on the dot-com companies attempting to adopt the biotechnology model of selling shares while operating at a loss.

Recognizing that the dot-com bubble had collapsed, investors next turned to the smaller "biotech bubble". While the dot-com IPO boom did have an impact on biotech, the size of this bubble was far less significant than that related to the internet. After all, it is the internet-based industries that are better understood by the investing public. Nevertheless, following the dot-com bust, biotech stocks fell. The investment community had had enough of high-risk markets and money dried up.

When I hear people tell me that the biotechnology business model is broken, I point out that the model never changed. It is today, what it was in the 80s - highly speculative and full of promise. What has changed, however, is the risk-tolerance of investors. Where biotech companies used to be able to obtain financing at research stages, they now find themselves lucky if they can attract financing when achieving positive results in phase II clinical trials.

While the biotechnology business model is not broken, it is obsolete. Clearly, investors want less risk and the future of innovative drug-discovery efforts depends upon the industry's ability to adapt during these challenging times. Unfortunately, no amount of adapting can fully bridge the divide from identification of development candidates to entry into clinical trials. The expenses are simply too high.

The interplay between innovation and venture financing has always been a partnership. Extending partnerships requires effort and compromise on both sides. While I routinely work with early stage companies to find cost-effective ways to advance their programs, the investment community must also come to the plate. This country was built on taking risks. Continuing our leadership in innovation requires continually taking risks. Ask the Crowley family. I am sure they would agree.

Monday, February 27, 2012

Life Science Careers - Questions from Soon-To-Be Graduates

Two years ago, I was invited to participate as a career mentor at the California State University Biotechnology Symposium.  At that time, I addressed questions asked by students contemplating careers in the life sciences - specifically relating to medicinal chemistry and drug discovery.  I had a great time meeting with the students and listening to their interests and concerns.  So, when I was asked to participate at this year's event, I readily accepted the opportunity.

At the time of my participation two years ago, the economy was at a very low point.  Pharmaceutical and biotechnology companies were routinely downsizing and outsourcing of chemistry was the rule rather than the exception.  However, the questions asked by the participating students were not focused on the economy.  Instead, the questions clustered into four distinct groups:
  • Questions about medicinal chemistry
  • Questions about career paths
  • Questions about employment opportunities
  • Questions about relevant knowledge and experience
What was remarkable about the questions coming from this years session was that the interests and concerns of the students were completely different compared to two years ago.  In this post, I present the questions raised by participating students.  Over the next few months, I will address each question in detail.  As I work through this exercise, I encourage all readers of this blog to ask additional related questions.

Questions Asked by Life Science Students

As in 2010, I was truly impressed with the questions asked at the mentoring session.  These questions, paraphrased below, reflect the evolving discussions encompassed by this blog.  The questions raised, organized by topic, are:

Questions About Education and Employment
  • In what ways can I be valuable to companies?
  • What are the differences between workforce personnel with undergraduate degrees vs graduate degrees?
  • How can practical experience be built favoring employment in medicinal chemistry?
  • What opportunities/career paths are available for foreign job applicants?
  • Does the quality of an educational institution carry any weight?
  • What perceptions exist relative to job applicants with degrees from foreign countries?
  • What are the financial benefits for PhD employees compared to BS/MS employees right out of school?
Questions About Roles and Opportunities in Drug Discovery Organizations
  • Are there interdisciplinary opportunities available for medicinal chemists in other functional areas related to drug discovery?
  • Is a PhD required to lead a project?
  • How do organic chemists interact with biologists?
  • Can a biologist become a medicinal chemist?
  • Is computational chemistry important to medicinal chemistry?
  • How does a molecular biologist fit into a drug discovery organization?
  • Is medicinal chemistry only relevant to drug discovery?
Questions About Medicinal Chemistry and the Drug Discovery Process
  • How does the drug discovery process begin?
  • What is involved in drug discovery from concept to market?
  • Is medicinal chemistry used in veterinary medicine?
  • Are animal models still used in drug discovery?
  • What is the transition point from animal models to human clinical trials?
  • How much medicinal chemistry is dedicated to making small quantities of many compounds vs large quantities of fewer compounds?
  • What is the importance of making derivatives of natural products?
  • Do medicinal chemists collaborate with physicians?
  • Do medicinal chemists collaborate with biochemists?
Questions About Business Strategies
  • Is there pressure to get new products out the door?
  • Can old drugs be used for new indications?
As with my previous series, it is my hope that those of you following this blog will add your voices and opinions to mine thus enhancing the breadth of insight provided to the next generation of students entering the life sciences workforce.

Wednesday, February 1, 2012

Recent Activities and Future Plans - I'm Still Here!!!

My apologies for the long delay since my last post.  Since beginning this blog, I strive to post at least once per month.  Unfortunately, due to a very busy end-of-the-year, blogging slipped.

As you are aware from the content of my posts and from my personal website (www.DELbiopharma.com), I am a consultant providing the following services:
  • design and implementation of medicinal chemistry programs
  • chemistry outsourcing management
  • technical due diligence
As a consultant, it is absolutely essential for me to continually network and market my services.  Time for these activities must be allotted in addition to the time that I spend working with my clients. From all aspects, the combination of scientific engagement and personal interactions is unparalleled to any employment situation I experienced prior to becoming a consultant.  That being said, I would like to focus this post on both highlights of the past 6 months and events planned for the near future.

Recent Activities

During the second half of the summer, I had a full load of clients - all with unique needs.  One in particular required the synthesis of several compounds within an extremely aggressive timeline.  After contacting seven different contract research organizations (CROs), I was able to identify one that was willing to take on this project within the parameters of the required timeline.  I am happy to say that this project, arguably the most difficult assignment I took on, was completed on time with all objectives met.

As indicated above, networking is critical to the establishment of a contract pipeline.  As such, I regularly go to local networking events and conferences.  The following is a list of groups I find particularly interesting in the San Francisco area:
In August, I was asked to present a talk at a BABCN event entitled "Creating Opportunities - Generating Consulting Income in a Hostile Market."  This talk was well attended and I received a great deal of positive feedback.

In January, I participated in the CSU Biotechnology Symposium as a career mentor.  The following week, I attended the JP Morgan Healthcare Conference.  One week later, I attended the Personalized Medicine World Conference.

As a follow-up to my BABCN presentation in August, I was invited to write a guest blog covering a key component of my consulting activities - identifying, engaging and managing CROs.  This blog was posted on January 31 and can be found at http://hamptonexecutivesearch.com/?p=1497.

Future Activities

Having brought you up to date from the past 6 months, the following is a list of plans for the near term.

As networking is essential to my ongoing consulting activities, I plan to attend the following conferences:
During the American Chemical Society meeting, I will be speaking as part of a symposium discussing chemistry careers outside of the laboratory.

Finally, as a follow-up to the CSU Biotechnology Symposium in January, I will be posting blogs addressing all of the questions raised at my table during the career mentoring session.  These posts will begin in February and continue until all questions are answered.

As always, I encourage you to bring up any topics you would like discussed in this forum.

Tuesday, July 5, 2011

Unnerving Trends in the Pharmaceutical Industry

"Houston, we have a problem."  This phrase, credited to the crew of the Apollo 13 lunar mission, has been used in many contexts (both seriously and comically) to describe difficult situations.  In worst-case scenarios, like Apollo 13, profound and life-changing (challenging) consequences may emerge.  In today's economy, one may paraphrase this to "ACS, we have a problem."

ACS (the American Chemical Society) is an organization dedicated to the promotion of the chemical sciences through educational programs, industry support and government lobbying.  Twice a year, it brings together thousands of chemists to exchange thoughts on the future of science, the status of academia/industry and government policy. Additionally, career resources are continually provided to aid ACS members in advancing their careers or identifying opportunities to regain or maintain employment.  Such resources are extremely valuable in these days of continued downsizing and outsourcing. However, even the ACS cannot create jobs where few exist.  In previous years, the back of Chemical & Engineering News was full of job advertisements for chemists.  Furthermore, the ACS sponsored career fairs were supported by hundreds of potential employers with jobs spanning all levels of experience.  I am sad to say that these advertisements are sharply diminished compared to previous years.  It is no secret that among sectors, the pharmaceutical industry is among the hardest hit.

Fully recognizing that these trends are industry-related and not the fault of the ACS, the question is now "what can be done to restore growth to the pharmaceutical industry?"  In order to answer this question, it is important to understand the causes of the present multi-year downturn.  These causes can be traced back to the marketing of "blockbuster" drugs and the resulting year-over-year double digit returns to investors.  As patent protection for the existing inventory of "blockbuster" drugs expires, the pharmaceutical industry is forced to look at lower revenues and increased competition from generics.  At the same time, the existing drug development pipeline is deficient in new "blockbuster" products to replace those going off patent.  Lower revenues coupled with continued demands from investors for high returns forces corporate downsizings.  Such downsizings are typically at the expense of research - the efforts generating long-term revenues.  With research departments minimized or eliminated, there are fewer quality products entering development - the efforts generating short-term revenues.  With fewer and/or premature compounds entering development, the likelihood of late-stage clinical failure is increased.  This trend directly results in decreased investor confidence.  With decreased investor confidence, there is less money available for investment in the pharmaceutical industry.  Less money means fewer jobs and fewer products advancing into the clinic.  IT IS THIS CYCLE THAT MUST BE BROKEN IN ORDER FOR THE PHARMACEUTICAL INDUSTRY TO RECOVER!!!

Emerging Trends in the Pharmaceutical Industry

Understanding the cycle leading to poor investor confidence is only the beginning.  In order to reverse the pharmaceutical industry's downward spiral, we must implement new paradigms and develop them to their full potential.  Such paradigms include:
  • personalized medicine - novel therapeutics with companion diagnostics
  • efficient use of both in-house and outsourced activities
  • streamlined processes enabling the "forced failure" of programs more likely to fail so efforts can be focused on programs most likely to succeed.
Regarding personalized medicine, I posted two articles on this subject (see postings on November 12, 2010 and February 27, 2011). Furthermore, the potential that can be realized through the ability to screen likely patients in order to assess their likelihood of responding to an experimental therapeutic is dramatic.  To cite data presented by James Sabry (Vice President of Genentech Partnering) at a recent networking event, 4000 drugs were tracked from clinical trial to market from 2004-2010.  Of this set of drug candidates, only 9% achieved FDA approval.  Broken down to the clinical stages, 63% advanced through phase I clinical trials.  Of the 63%, only 33% advanced through phase II clinical trials.  Of that 33%, 55% advanced through phase III clinical trials.  Finally, 80% of those advancing through phase III received approval.  In order to restore investor confidence and rebuild our industry, these percentages must rise. Through exclusion of clinical trial participants lacking necessary biomarkers, these percentages will increase.

Regarding the combined use of in-house and outsourced activities, I continually comment on industry trends, employment challenges and novel career opportunities.  Two postings on these topics (see postings on August 21, 2009 and October 25, 2009) go into great detail regarding current and emerging trends.  The reality is, outsourcing is here to stay.  Once accepting this reality, potential new opportunities come to light.  In the May 9, 2011 issue of Chemical & Engineering News (pg 48-51), I was quoted regarding trends and opportunities in "Managing Outsourcing."  Specifically, as organizations continue to view synthetic chemistry as "outsourceable," these same organizations recognize that management of these activities requires one both skilled and knowledgeable in the science of organic/medicinal chemistry. Problems always arise when working with CROs.  Success is dependent upon how efficiently these problems can be addressed. Furthermore, simply being able to prepare compounds is not a replacement for the ability to design the right compounds to prepare. In my experience, the most efficient combination of in-house and external resources utilizes a small internal infrastructure for development of robust synthetic methodologies in concert with the technical talents of CROs for the synthesis of targeted compound series dependent upon these methodologies.

Regarding streamlined processes, early drug discovery efforts were somewhat linear with compounds advancing through one assay at a time.  By utilizing batteries of assays to evaluate structural classes, early indications regarding pharmacokinetics, metabolism and toxicity can be established.  Structural series failing to demonstrate early acceptable properties can be terminated in favor of those showing promise.  Through "forced failure," more money is spent earlier to save even greater amounts by not advancing sub-optimal compounds into development.  Finally, referring to the percentage of drug candidates advancing through phase I clinical trials mentioned above, the "forced failure" paradigm holds the potential to positively impact this statistic.

The Future of Employment in the Pharmaceutical Industry

While the above describes trends likely to result in greater success and return on investment, it does little to address the current state of employment in this industry.  While the unemployment rate in the United States is around 9.1%, the unemployment rate in the pharmaceutical industry (including biotechnology) is almost twice that.  While disheartening, I continually post on strategies for maintaining employability as well as what types of opportunities are available for those displaced in a shrinking job market.  Additionally, in the April 18, 2011 issue of Chemical & Engineering News (pg 49-51), I was quoted in an article focused on "Survival Skills."  The lessons are more relevant now than ever - those currently unemployed must find ways to stay active in this industry or risk not finding employment as conditions improve.  In today's economy, there are plenty of reasons for not getting paid.  However, there are no excuses for not working.

Even with the unemployment trends, there are those who have the potential to influence policy and, at least partially, restore growth to this industry.  These individuals are our congressional leaders and big-pharma executives.

In the current state of the pharmaceutical industry, large companies have turned to small biotechnology companies to enhance their development pipelines.  However, these deals, especially for earlier stage compounds, come with high milestone payments.  Consequently, deals between large and small companies are dissolving in attempts to minimize these payments.  The unfortunate result is small companies being forced to develop their products without the backing of larger organizations.  The increased corporate expenses related to clinical development often result in significant corporate downsizings - thus compounding the current employment climate (Chemical & Engineering News, June 20, 2011, pg 15-20).  In an industry where high risk yields high reward, the current risk adverse nature of those influencing the pharmaceutical industry continues to result in downward pressure on the economy.  Downstream, these trends will inevitably be reflected in fewer new products and continued medical indications with no available effective treatments.

With the number of highly innovative scientists displaced due to mergers, outsourcing and downsizing, the talent pools in both local industry hotspots and nationwide are unprecedented.  Even so, John Lechleiter (CEO of Eli Lilly & Co.) is lobbying for US immigration officials to issue more green cards for highly skilled immigrants. While I am all for opening up opportunities for the most qualified individuals, isn't it incumbent upon us to first look after those who, through no fault of their own, found themselves unemployed?

Regarding the rich pool of available talent, the trends and paradigms discussed in this posting should generate a great deal of optimism. Once the dust settles and new business models emerge, growth will return.  Furthermore, with appropriate financial resources, the available talent pools will inevitably give rise to a new generation of start-up companies creating new opportunities for innovation.  As Apollo 13 began with a problem and returned safely home, so too will the pharmaceutical industry.  After all, we are a growing and aging population.  We will always need to eat, we will always generate garbage and we will always require medication.

Tuesday, March 29, 2011

Organic Chemistry Degrees - Training in Thinking vs Training in Doing

A recent editorial in Chemical & Engineering News, along with an accompanying article, has had me thinking about the future and quality of our educational programs.  The editorial entitled "Too Many Ph.D.s?" and the article "Doctoral Dilemma" both appeared in the January 31 issue and, not surprising, have received significant interest and responses.  Presently, I am attending the Anaheim ACS meeting and, in light of the high caliber of science being presented around me, I feel a need to add my thoughts to this discussion.

I received my PhD under the supervision of Professor Satoru Masamune at the Massachusetts Institute of Technology.  As part of my graduate studies, I was responsible for the design and execution of synthetic strategies leading to the total synthesis of Calyculin A.  Those of you who may be familiar with this natural product will recall that it is a highly structurally diverse molecule with an aminosugar unit, a heterocycle, a spiroketal and a tetraene.  The two fragments I worked on were the aminosugar and the tetraene.  In addition, I designed a novel approach for the introduction of necessary chirality adjacent to the heterocycle.  In all cases, my efforts began with an exhaustive study of the target structures as matched with the structures of available starting materials and availability of key reagents.  At no time did I receive instructions as to how I was to approach my assigned tasks.  Instead, I was given the freedom to execute on my ideas and drive these efforts as far as they could go based upon the available technology.  I would not be honest if I suggested that each attempt worked as planned.  However, each strategy, successful or not, allowed me opportunities to ask questions, find answers and evaluate results.  My technical experience was a byproduct of the extensive chemical studies I pursued.  After all, how could I answer questions without doing the experiments.

My undergraduate research activities, in contrast to those in graduate school, fell under the tutelage of Professor Henry Rapoport.  In his labs, I was assigned specific tasks with generally understood protocols.  My role was initially to support the efforts of a post doc. Later, I was assigned more independent studies allowing me to begin thinking about chemistry rather than simply following instructions. So, when comparing my undergraduate experiences to my graduate studies, Rapoport taught me how to do chemistry and Masamune provided me the opportunity to teach myself how to think about chemistry.  Both experiences were essential to my academic and professional development.

Current Educational Programs - Are We Training Too Many Ph.D.s?

In the present job climate, there is no question that medicinal chemists have endured more than their fair share of problems.  With the continuing trend of corporate takeovers and subsequent shutdowns, there is plenty of available talent with nowhere near enough new jobs being formed to absorb the unemployed.  At the same time, graduate programs continue to produce a new generation of chemists eager to enter the workforce.  In anticipation of the extremely high level of competition for any available position, I have heard it argued that some graduate student mentors are tailoring their programs to meet specific needs of companies.  If true, this type of "apprenticeship" risks compromising the quality of the PhD degree in favor of the short term benefit of "grooming" students for entry into chosen professions.

As I discussed in the first section of this post, a complete education involves a combination of technical and intellectual training.  Without a firmly established ability to generate and test independent hypotheses, an advanced education would be incomplete.  After all, as "PhD" stands for "doctor of philosophy," is it an unfair expectation that those holding such a degree should be capable of generating and testing their philosophies - even when they differ from more conventional thinking?  Without new thoughts and ideas, progress will come to a complete standstill.  That having been said, I have not been in the academic setting for many years and cannot evaluate the current trends beyond what is reported.  I can only hope that the quality of advanced education today remains as high as it was when I received my PhD.

Returning to the question of whether we are training too many PhDs, the ability to think is not restricted to an individual field of thought. If one is capable of imagining, endless possibilities become available. This applies not only to the advancement of technology, but also to professional development.  Yes, the job market is unstable.  Yes, there are few available jobs.  Yes, there are many unemployed chemists.  However, there are numerous areas where creativity can lead to exciting career options - even if not along envisioned paths. As I have communicated throughout this blog, the key to success is not along one path.  Today, it is essential to continually learn new skills, reinvent oneself and be adaptable to opportunities presented. From this philosophy, it is not the number of PhDs that we need be concerned about, but rather what we are preparing our PhDs to do.  If we train PhDs to think creatively, as I believe we do, there is no limit to what can be accomplished.

Sunday, February 27, 2011

Personalized Medicine - Additional Thoughts

Since my posting on personalized medicine (November 12, 2010), I had many discussions with my colleagues and peers regarding the true utility of genetic screening and the utility of biomarkers in establishing appropriate therapeutic regimens.  While many agree with me regarding the promise of this approach, there are some dissenting opinions - most of which limit the reach of personalized medicine to cancer and bacterial infections.  Regardless of opinion, a recent presentation by James Sabry (February 17, 2011 - www.growbold.com) would have been of great interest to all camps.

In his discussion, Sabry argued that the success rate for new drug approvals suffers, in part, from heterogeneous patient populations. Specifically, these patient populations include groups that are genetically pre-disposed to be non-responders.  If we could screen out these non-responders from any clinical trial, drug response rates are likely to improve and more clinical endpoints will be met.  The result, while relevant to smaller patient populations, will be better therapeutic agents.  The key to all of this lies with the development of diagnostic tests for pre-screening patients prior to prescribing medications.  In the cancer arena, Genentech is taking a lead position with the development of disease-specific antibodies tethered to chemotherapeutic agents.  While, at present, this will not address all forms of cancer, I believe that this strategy is moving in the right direction.

The Rx/Dx Model - What it Means for Big Pharma

One of the challenges facing the pharmaceutical industry relates to the market potential of any given product.  After all, the drug industry, like any other, is a money-making enterprise with financial responsibilities to investors.  As such, the larger the market potential of a given product, the more attractive the program to large companies.  To put this in another perspective, it is far easier for a company to earn one billion dollars per year from a single product than it is to earn the same amount from ten products with markets of one hundred million dollars per year.  Aside from the reduced number of programs to manage, fewer dedicated personnel are required in areas such as sales/marketing, QA/QC and manufacturing.

In order to obtain blockbuster status, therapeutic agents must target the largest potential patient populations.  However, these patient populations are heterogeneous and include various sub-populations - many of which will not respond.  From an economic standpoint, this does not matter to business as long as the therapeutic does no harm. However, the waste associated with the money spent on products not benefiting patients is significant.  Introduction of companion diagnostics, while beneficial to patients, will likely reduce the potential market size of therapeutic agents resulting in lower profits for drug companies.  I FIRMLY BELIEVE THAT THIS SHOULD NOT BE A CONSIDERATION FOR DRUG COMPANIES!  After all, if a patient will not respond to a given drug, that drug should not be sold to that patient.  In further support of this assertion, Sabry, in his February 17 talk, argued that pharmaceuticals should only be paid for if they work.  While such business models don't currently exist, there is a great deal of merit to this argument that can only result in better products.

Regarding the potential reduced markets for diagnostic-coupled therapeutics, this should not be a deterrent to the pharma industry. To the contrary, this paradigm has great potential.  If diagnostics can differentiate large populations into smaller responsive populations, they can also define additional patient populations suffering from conditions with unmet medical needs.  Furthermore, additional revenue will be realized from the diagnostics which, as a screening tool, will be used on all patients seeking treatment for ailments with established biomarkers.  While the number of blockbuster drugs is likely to decline, the Rx/Dx paradigm is a potential gold mine of opportunities poised to improve the efficiency of drug discovery and the overall quality of healthcare to the general population.