On March 1st, the Boston CMO Network sponsored its second event. Dr. Robert Temple, presented to a group of 80 physician executives from Boston area biotech and pharmaceutical companies on the topic of “Creating Efficiencies in Clinical Trial Design”. Dr. Chris Wright, SVP, Global Medicines Development and Affairs of Vertex Pharmaceuticals was host of the event, which was held at Vertex facilities in Cambridge, MA.

Dr. Robert Temple is Deputy Center Director for Clinical Science of FDA’s Center for Drug Evaluation and Research and is also Acting Director of the Office of Drug Evaluation I. Dr. Temple received his medical degree from the New York University School of Medicine in 1967. In 1972 he joined CDER as a review Medical Officer in the Division of Metabolic and Endocrine Drug Products. He later moved into the position of Director of the Division of Cardio-Renal Drug Products. In his current position, Dr. Temple oversees ODE-1 which is responsible for the regulation of cardio-renal, neuropharmacologic, and psychopharmacologic drug products. Dr. Temple has a long-standing interest in the design and conduct of clinical trials and has written extensively on this subject, especially on choice of control group in clinical trials, evaluation of active control trials, trials to evaluate dose-response, and trials using “enrichment” designs.

Enrichment Designs in Clinical Trials

Dr. Temple discussed the many ways to show drug effect in smaller trials that are encompassed in the concept of enrichment, which is the subject of a future FDA guidance document.



A clear benefit of selecting high-risk patients is the ability to have enough endpoints to demonstrate a possible drug effect, at least in one group of patients. Of course, there is always a question about the benefit/risk equation in patients with lower risk, which usually requires additional study.

Randomized Withdrawal Studies

Dr. Temple also discussed the use of Randomized Withdrawal studies to show long term effectiveness or determine how long patients should be treated. He cited the challenges of showing a benefit vs placebo in a cyclical disease, such as depression, when treating people for only a short period of time. Randomized withdrawal can be used to demonstrate the benefit in prevention of the next episode of depression in these patients.



Dr. Temple’s presentation was followed by a Q&A session.

About The Boston CMO Network

The Boston CMO Network includes senior physician executives in the greater Boston area who are active in the biotech and pharmaceutical industry. The Network sponsors events for Boston-area physician executives to meet, interact and learn from each other.

A Steering Committee of physician executives plans the group’s events, which are hosted at local biotech companies. The Boston CMO Network expects to hold its next event in June, 2012.

A couple of years ago I went to a meeting in Washington, DC, to be a part of the conversation on the value of Health Economics and Outcomes Research (HEOR) within the biopharmaceutical and device industry. It was a great meeting, mostly attended by people who were intimately involved in HEOR in their every-day lives. It was also somewhat spooky. None of the presenters had shared thoughts prior to the meeting. Yet everyone’s message was oddly aligned: we need more quality HEOR studies earlier in technology development.

There was broad consensus that most companies need a better understanding of the role, methodologies, and value of HEOR within their development programs. And while clinical trialists are a well appreciated asset in the industry, HEOR groups still tend to be the red-headed step children. They get little buy-in from other departments and minimal support from the leadership, and their output is viewed with suspicion. To be sure, there are companies who understand the role of HEOR, and these are the success stories. But many remain in the dark. The message at the meeting was clear, albeit a bit paradoxical: we must do a better job articulating our own value proposition!

There are many compelling reasons why this needs to happen. The 21st century healthcare landscape is filled with tremendous challenges that are here to stay. While 20 years ago all of the emphasis in drug development was on the FDA approval, today, in our economically constrained healthcare system, no approved technology can succeed without articulating what value it brings to the table. Therefore, the industry cannot afford to lag behind the payor community in their understanding of economic arguments. For the manufacturer who is willing to accept them, these challenges create an opportunity to become a real partner in patient-centered, high quality, efficient healthcare delivery.

I have always argued that a manufacturer needs to be the biggest expert on the disease being pursued and its treatment; and this, I believe, is largely the case. Yet by necessity this expertise must extend to the value proposition for their technologies that goes well beyond the statistically significant improvements over placebo required by the FDA for approval. We must develop objective milestones by which to judge worthiness of technologies in development at every point in the development process. Those who do, will adapt to and succeed in this atmosphere of cost controls. Those who don’t, do so at their own peril. It is imperative to engage in this ongoing evaluation of our innovations with a critical eye to what value they will bring to the society.

“We are rapidly becoming the major biotech/pharma hub in the US.  As senior medical leaders, we should be meeting to discuss critical industry issues, network, and expand our horizons beyond the day-to-day activities in our respective organizations.  We can learn about progress, share our experiences & ideas and, of course, describe our challenges and success stories.” Akshay Vaishnaw, Chief Medical Officer, Alnylam Pharmaceuticals

The idea for the Boston CMO Network grew out of discussions between Akshay Vaishnaw, Chief Medical Officer for Alnylam and other senior physician executives in the Boston biotech hub.  They all recognized a need for Boston-area biotech and pharma medical leaders to meet periodically to exchange ideas, network, and share interesting news and opinions. Steve Rauscher of BioPharm Physicians worked with the group to organize and plan activities.  Al Sandrock, SVP of Medical Research-Neurology at Biogen Idec graciously agreed to host the first event.

Boston CMO Network Inaugural Event

On November 10, 2011, the Boston CMO Network held its first networking event at the Biogenic Idec Cambridge campus.  Fifty senior physician executives from the Boston area biotech and pharmaceutical industry gathered to hear Christoph Westphal MD PhD, Founder and Partner of Longwood Fund, present “Ups and Downs for Drug Innovation — a Dozen Years in Boston Biotech”.  A lively Q&A session ensued, which continued during the reception that followed.

Future Events
Attendees were surveyed about upcoming events.  Most recommended that 3 or 4 events per year would be the ideal frequency.  Suggested ideas for future topics included the following:

The next Boston CMO Network Event is planned for late February or early March, 2012

Pharma Strategy Blog

One of our favorite blogs is the Pharma Strategy Blog authored by Sally Church, PhD.  Sally provides “Commentary and insights on Pharma & Biotech new product development with a focus on oncology and hematology.”  It is a must-read for anyone in the oncology and hematology space.

One of Sally’s recent posts, “On T Cells and chronic lymphocytic leukemia” provides an excellent overview and a more measured interpretation of the results from a small pilot study done by University of Pennsylvania researchers David L. Porter, MD, Carl H. June, MD, and colleagues.  Much of the coverage in the general media over the results of this small study was clearly overblown.

Applied Clinical Trials Online

This is the blog for the online version of Applied Clinical Trials magazine, “the global, peer-reviewed journal whose coverage features the process of managing clinical trials at the intersection where pharmaceutical product developers meet the strictly regulated medical researchers who test their new drugs.”

A recent post on this site, The Confusion Surrounding Comparative Effectiveness Research, was authored by Richard Gliklich, MD, the President of Outcome Sciences.  The post discusses some of the issues and confusion around comparative effectiveness or patient-centered outcome research.

On Biostatistics and Clinical Trials

This blog is authored by Chunqin (CQ) Deng, who describes himself as “A Medical Doctor turned into Biostatistician in Clinical Trial and Drug Development.”  In his blog, he discusses issues in biostatistics and clinical trials.  A recent post, Equipoise and Lack of Equipoise in Randomized Clinical Trials, discusses a clinical trial design approach that Dr. Deng and his colleagues used to overcome the lack of equipoise in a trial using IVIg, (intravenous 10% caprylate-chromatography purified immunoglobulin) for the treatment of CIDP, (chronic inflammatory demyelinating polyradiculoneuropathy).

Guest Post from Tomasz Sablinski, MD, PhD

FDA’s Janet Woodcock recently testified to a subcommittee of the House of Representatives that drug approvals in 2011 may be headed for a 20 year high.  However, most of the news in the industry lately has been negative.

As noted in Fierce Biotech:

A long-time drug developer in the industry, Tomasz Sablinski, MD, believes the industry needs new and novel approaches in drug development.  In addition to his role as Head of Development at Celtic Therapeutics he recently founded Transparency Life Sciences, and is inviting a diverse audience of patients, providers and scientists  “to help create the world’s first open-source, completely transparent drug development organization”.

Dr. Tomasz Sablinski is the Head of Clinical Development and a member of the Executive Committee of Celtic Therapeutics Development (CTD).  He is Founder of Transparency Life Sciences. Prior to joining CTD, Dr. Sablinski served as Vice President at Novartis in charge of US Clinical Development and Medical Affairs. Prior to this, Dr. Sablinski held several leadership positions at Novartis headquarters including Vice President of Clinical Research and Development and Head of Global-Japanese Coordination. He also held multiple leadership positions in Novartis’ Transplantation Business Unit. He participated in, and supervised numerous NDA and IND submissions in the US, Europe and Japan.

Dr. Sablinski joined the Pharmaceutical Industry with Parexel in the mid-nineties as  Medical Director. Prior to joining the pharmaceutical industry he conducted basic research while appointed as Instructor of Surgery at Harvard Medical School, Massachusetts General Hospital, and Fellow at the Brigham and Women’s Hospital in Boston. His other clinical appointments include Lahey Clinic, Burlington, MA, and Central Clinical Hospital in Warsaw, Poland.

Dr. Sablinski earned his MD and his Ph.D. in transplant immunology at Warsaw Medical School.

Dr. Sablinski sat down with BioPharm Physicians to talk about innovation in drug development.

BioPharm Physicians: Dr. Sablinski, you’re involved in two organizations, Celtic Therapeutics and Transparency Life Sciences. Both are using novel approaches to drug development.  Can you begin by telling us a little about Celtic?

Dr. Sablinski: Celtic Therapeutics is a limited partnership private equity fund focused on drug development.  Unlike a classic venture capital or private equity partnership, we focus on acquiring and developing promising new therapeutics using a small team of experts and a virtual drug development model.  The goal of the partnership is not to build new companies.  Rather, the goal is to build value in new products through smart, cost-effective development and then sell or out-license those products to pharmaceutical companies for downstream commercialization.

We are building and developing a diversified portfolio of products in quite diverse areas including ophthalmology, Amyloid A (AA) amyloidosis and variety of cancer indications.  Our approach is novel, since we avoid the costs and overhead associated with building individual companies.  We focus only on building value in individual products.

BioPharm Physicians: What have been some of the biggest challenges in the virtual drug development model?

Dr. Sablinski: Traditionally, many have viewed “virtual” development, as inferior to a “bricks and mortar” approach. Thus, the first challenge is to convince external audiences (development partners, investors) that the main reason to be virtual is not the shortage of money, but rather the superiority of the approach versus one that calls for using resources to build a stagnant “built to last” organization.

The second challenge is to find the right people.  There is no room for free-riders in a super-dynamic, content–centered and transparent development environment. The engagement of contributors starts and ends with an enthusiasm for the content, and from applying one’s expertise to contribute to moving a project forward.  It is increasingly easier to identify people who share such a mindset, and knowledge networks such as LinkedIn and your community of physicians are great enablers.

Another interesting challenge is to appropriately reward contributors who will often meet in the “cloud” only – different models exist and are successful in other industries.

Drug development in our industry has not yet embraced and faced these challenges. It is not surprising, as in my estimate this industry is about a decade behind other industries in effective use of computers  and new information technologies.  Unfortunately, this decade-gap is widening rapidly, and I do not think it can be bridged without a radical re-engineering of the entire model.

BioPharm Physicians: You’ve recently launched Transparency Life Sciences.  Can you describe for us what you hope this new initiative can accomplish?

Dr. Sablinski: Transparency Life Sciences (TLS) is a web-enabled biopharmaceutical company whose mission is to develop medicines for significant unmet medical needs, using a fundamentally superior approach compared to current industry standards. Initially, TLS will focus on acquiring and re-directing the development of compounds that have demonstrated a signal of efficacy, and a clean safety profile, but are “on the shelf” as a result of poor alignment with the owner’s corporate strategy, unsuitable properties for the current indications of interest, or financial reasons.

Transparency Life Sciences will develop products using a game-changing approach based on three pillars:

As a result we hope to develop much less expensive medications, much faster and with relevance and quality of data exceeding today’s standards.

BioPharm Physicians: Can you discuss the importance of an open-sourced approach and the value of transparency in drug development?

Dr. Sablinski: The value of this approach to product design has been well proven in software (Linux), and many other industries. It is increasingly recognized as a valuable method in basic research, and drug discovery (references available on request). However, no company has adopted cIQ as a way to design, execute, and analyze clinical studies – the crucial, most expensive and most time-consuming part of the development of new treatments.

With open-sourced development, anyone anywhere will be able to contribute to the planning and design of TLS compound development strategies and tactics in real-time. By granting full data access to a broad expertise, the TLS open source approach will add substantial value to its pipeline of products, benefiting TLS stakeholders, partners, and product acquirers. Algorithms and filters to manage crowd input will be implemented to enable efficient processing of information. A reward system will provide incentives to users offering high quality, high impact contributions. Based on the open source approach, TLS can cover a wide range of therapeutic areas and diversify overall business risk.

In contrast to the historical approach taken by Pharma companies in most aspects of their business, TLS believes that the benefits of working in a transparent environment far outweigh the risks. Pfizer, Merck, Lilly and others have recognized this value, and launched “open source” efforts in early research to supplement and improved the productivity of their internal discovery efforts. TLS however believes that transparency should facilitate every step of its business process, from evaluating and selecting compounds for acquisition; developing the clinical plan and study protocols; recruiting and executing studies; processing, analyzing and interpreting data; regulatory and reimbursement discussions; and ultimately making decisions related to potential asset sales.

BioPharm Physicians: The industry faces tremendous challenges in improving its research productivity and reducing the cost of late stage failures in development.  What are your thoughts on some of the things that industry physicians need to consider to improve R&D productivity?

Dr. Sablinski: I have a very clear and blunt message here:

1. Do not waste time attempting to improve existing model(s) of clinical stages of drug development, as these are based on mid – twentieth century principles and completely ignore the fact that we live and operate in the world driven by technology. Consequently, these approaches are, in fact, trying to adjust the world around you to fit the glacial pace of change in the industry.  They will fail.

2. Look for successful models in other industries, particularly in computer sciences and information technology.  Adopt and try them in drug development.

Guest Post from Lindsay McNair, MD, MPH

Like many physician drug developers, I’m always interested in attending meetings that will enable me to make new connections, learn new things and earn some CME credits.

A couple of weeks ago, I attended the Drug Information Association (DIA) Annual Meeting for the first time.  This guest post shares some of my observations.

Having heard about DIA over the years, I thought the annual meeting would be a huge conference.  It seemed smaller than I expected.  Perhaps, I was comparing it to this year’s annual ASCO meeting, which I had attended a few weeks before at the same conference center, McCormick Place in Chicago.

Physician Drug Developers – Not the Primary Target Audience

I was at the DIA meeting for 2 days and attended several of the educational sessions.  There is no “track” of sessions that is really applicable to the physician’s role in drug development, although there were some sessions of interest sprinkled across the other tracks.  Although each session’s description indicated whether it was intended for a beginner, intermediate, or expert audience, I thought that the content of sessions tended to be fairly basic for anyone with more than a few years of experience in drug development.  The session I found most interesting was one which had speakers from FDA (DDMAC and APLB) talking about interpretation and enforcement efforts in advertising, which also included some interesting discussion based on audience questions.

CME Credits Limited for Physicians

At least in Massachusetts, where the Board of Registration has recently announced that they will start doing random audits of CME documentation (which they have always said they could do, but apparently they now mean), obtaining CME credits for meetings was of particular interest.  Unfortunately, there were not many sessions that offered CME credit for physicians (although many that offered pharmacy, nursing, or other credits). Several of the sessions offering physician CME credit were about very specific therapeutic indications (for example, discussion of developing biomarkers as endpoints for X disease studies).  In some ways, the meeting was very high-tech; your badge had to be scanned by the person at the door of the meeting room to be credited as having attended, and at the end of each day an email arrived with links to the evaluations for the specific sessions you had logged in for.  On the other hand, some of it was frustrating; after completing all my evaluations the day after the meeting, I was unable to figure out how to print my CME certificate, and it turned out that 1) CME credits would not be accessible for another week and 2) you had to go under a whole different section of the website, which I never would have discovered, to get the CME form printed out.

The Exhibits – A Big Draw

The exhibit hall at the meeting was fairly large, and unlike current medical meetings, included lots of free stuff given away by vendors of every type:  general and niche CROs, laboratories, independent institutional review boards, meeting and event planning companies, etc.  My impression is that for lots of clinical operations people the exhibit hall is a main draw of the meeting for identifying potential new vendors, and it was certainly busy at all the times I stopped by.

Overall Conclusions

While the DIA meeting may be a good one for monitors, study coordinators, pharmacists, regulatory personnel, project managers and clinical operations professionals, I don’t think it is a great meeting for physician drug developers.  It’s not a meeting I’ll make a special effort to attend in the future.

What do you think?  Did you attend DIA this year?  What did you think of it?  Did I miss the good parts?

Aside from clinically-oriented (or therapeutic area-specific) medical meetings like ASCO, what conferences or resources do you, as a physician drug developer in, find most interesting or useful?

Dr. Lindsay McNair is Owner & Principal Consultant for Equipoise Consulting. She is an experienced pharmaceutical physician with a thorough understanding of the integration of science, medicine and business necessary for drug development and marketing. Dr. McNair has more than 10 years of experience in clinical research and drug development strategy. She has managed clinical development strategies for new drugs, and has overseen the design, conduct and medical monitoring of all phases of clinical trials. Dr. McNair is also experienced in medical affairs and marketing planning, has provided medical review for marketing materials and other physician-oriented collateral, and is familiar with DDMAC and other regulations. She is an experienced public speaker, and has led and moderated many thought-leader advisory boards for clinical development and marketing strategies.

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Translational Research involves the extensive body of work required to move a discovery from “bench to bedside.”  It has become a high priority with academic research institutions and NIH.  In 2006, Congress created the NIH Common Fund “to support cross-cutting, trans-NIH programs that require participation by at least two NIH Institutes or Centers (ICs) or would otherwise benefit from strategic planning and coordination”.

The Common Fund developed two initiatives on Translational Research:

The NIH funding for CTSA in 2006 was $243 million.  CTSA now has 55 members.  When all 60 institutions are funded, the annual budget for NIH will be $500 million.

New Trends in Academic-Industry Collaborations

In addition to NIH funding, universities are increasingly forming direct collaborations with pharmaceutical companies in Translational Research, (see following examples).  In most cases these involve multi-year programs in which the drug company sponsors research and has an option to license the discoveries emerging from that research.  Often, a joint steering committee is involved in the identification of lead compounds and management of Translational Research.

In theory, these collaborations will allow university researchers to develop greater expertise and exert greater influence over Translational Research via the joint steering-committees.  Additionally, the results of Translational Research would get fed back to the university research teams.

As these University-Pharma collaborations are relatively new, it remains to be seen if they will result in improved R&D productivity and a more cost-effective path to commercialization of university-based discoveries.  It also remains to be seen how these collaborations will affect the broader mission of CTSA.  There may be an inherent conflict of interest between the desire of an industry partner to protect confidentiality and develop intellectual property and the goal of CTSA to encourage cooperation, communication and the diffusion of technology and information.

What do you think?  Will these new partnerships speed the movement of university discoveries from bench to bedside?

* (Image from City of Hope)

On May 31, 2011, FDA approved Dificid (fidaxomicin) tablets for the treatment of C. difficile Infection (CDI).  The approval was based on two trials that included 564 patients comparing Dificid to Vancocin (oral vancomycin), the only currently approved treatment for CDI.

In the pivotal clinical trials, Dificid demonstrated comparable efficacy to Vancocin at end-of-treatment, but a lower rate of CDI recurrence than Vancocin.  “Sustained clinical response 25 days after the end of treatment was 70% for DIFICID-treated patients in the first trial and 72% for DIFICID-treated patients in the second trial [95% CI], compared to 57% in both trials for vancomycin-treated patients [95% CI]”.

Will this difference in relapse be enough to ensure significant commercial success for Dificid or will the market demand additional data?  Here the story becomes more complicated.

The Infectious Disease Society of America (IDSA) and the Society for Healthcare Epidemiology of America (SHEA) published updated new guidelines for the clinical treatment of CDI  in May, 2010:

• “Metronidazole is the drug of choice for the initial episode of mild-to-moderate CDI”
• “Vancomycin is the drug of choice for an initial episode of severe CDI”
• “Treatment of the first recurrence of CDI is usually with the same regimen as for the initial episode …but should be stratified by disease severity (mild-to-moderate, severe, or severe complicated), as is recommended for treatment of the initial CDI episode”
• “Do not use metronidazole beyond the first recurrence of CDI or for long-term chronic therapy because of potential for cumulative neurotoxicity”
• “Treatment of the second or later recurrence of CDI with vancomycin therapy using a tapered and/or pulse regime is the preferred next strategy”

Given the current guidelines, how will hospitals and physicians react to the availability of Dificid?  We think they will be cautious for several reasons:

Additionally, generic versions of Vancocin are expected to come to the market soon, which will dramatically lower the cost for oral vancomycin therapy.  This means that hospitals will have two cheap generic antibacterials that will work for most patients.  How will they choose to use Dificid?

One can imagine that many hospitals may choose to put Dificid on a tightly restricted formulary.  Patients may receive Dificid only if they have severe disease and have failed a course of treatment with Vancocin or are expected to be in the hospital for a sustained period of time.

As with many drugs, the sponsor, Optimer, may have done enough work to get the product approved, but may need to do additional work to achieve commercial success.  Perhaps Optimer should consider answering the following questions in additional studies:

What do you think?  What additional studies would you consider if you were trying to maximize the commercial success of Dificid?

Dr. Timothy Leach is Owner of InterimMD, a private consulting firm.  His experience as a consultant in both large and small companies ranges from IND filings through NDA approvals and post-marketing studies.  He has worked extensively with both small and large molecules across multiple therapeutic areas including infectious diseases, vaccines, orphan metabolic/genetic diseases, oncology and inflammation.  In this interview he shares some of his thoughts on his career as an industry physician.

BioPharm Physicians: Dr. Leach, after completing your internship and your boards for Internal Medicine, you spent four years as a commissioned officer in the US Navy, attached to the Marine Corps.  You are a veteran of the first Gulf War.  How did your time in military service affect your career as a physician?

Dr. Leach: The military is all about discipline and good order, with strict adherence to procedures and protocols. It teaches good habits like planning early, working methodically and sticking to schedules. Although not as regimented, drug development shares these common principles with the military.  Long range plans help you anticipate problems and work out contingencies for them in advance.

The military is also about knowing your place. While military commanders will defer to medical officers over medical issues, it is also clear that as a physician you are no more important to the mission than any other line function. My time in the military helped me appreciate this, and the importance of teamwork.

BioPharm Physicians: After your service in the Marine Corps, you completed your fellowship and boards in Infectious Disease.  What drew you to that specialty?

Dr. Leach: I became interested in infectious diseases because of my military service. I was attached to a marine helicopter squadron, and like all marine units they were constantly prepared to pack up all their “bullets, beans, and band aids” on a moment’s notice for a sustained deployment anywhere on earth. My duties required that I anticipate and prepare for diseases of tactical importance–those that could potentially degrade unit readiness.

Some of these diseases were endemic infections, and were preventable via chemoprophylaxis (like malaria) or vaccination (like yellow fever), while others were caused by agents of unconventional warfare (nuclear, biological or chemical weapons). Of the biological weapons, anthrax is best known, although there are many other infectious agents or toxins (plague, staphylococcal enterotoxin) that have been weaponized. I had little familiarity with these diseases during my residency, and the military approached these diseases from the perspective of preserving the unit’s combat readiness, in essence a public health function. In many ways this parallels what we do in the pharmaceutical industry by developing new drugs, not for any particular individual, but for the common good.

BioPharm Physicians: What did you do following your fellowship and how did you decide to join the pharmaceutical industry?

Dr. Leach: I was a staff infectious diseases physician at the East Orange VA, and on the clinical faculty at the University of Medicine and Dentistry of New Jersey teaching residents and students. I found the daily routine of clinical infectious diseases had very little in common with what drew me to the specialty in the Marine Corps, and after practicing for several years, I responded to an unsolicited call from a recruiter who was filling a position at Pharmacia and Upjohn in the linezolid (Zyvox) program. When I interviewed, I was surprised at how happy all the physicians were. At the time, linezolid represented the first agent in the oxazolidinone class.  This was the first new class of antibiotics in development in about 30 years. I thought I’d try it for a year thinking I could always return to clinical medicine if I didn’t like it.  I’ve never looked back.

BioPharm Physicians: In addition to your experience as an officer in the military, and your board certifications in Internal Medicine and Infectious Disease, you are also Shea/CDC certified in Hospital Epidemiology.  How has that training influenced your industry experience?

Dr. Leach: As a hospital epidemiologist, I learned that there were many things that go on behind the scenes, outside of the wards and clinics, that if performed incorrectly (like disinfection of endoscopes), could have significant effects on the well-being of patients, and it is therefore important to understand what goes on in the hospital’s support systems.

Hospital epidemiologists also need to be able to identify problems early and recognize that even single events can represent an epidemic. For instance, a hospital should never wait for a second case of Legionnaire’s disease before acting.

Like my experience in the Marine Corps, these lessons also have correlates in the drug industry. Industry physicians need to be familiar with the entire process of drug development, not just the clinical protocols, but all the mechanics behind them. Similarly, signal detection is a critical function to protect the safety of trial participants. There’s no foolproof way of differentiating between a problem and a random event, but there needs to be a methodical investigation just like in hospital epidemiology.

BioPharm Physicians: What were some of the surprises as you adjusted to working in the industry?

Dr. Leach: A lot of people thought I was making a mistake when I announced my plan to leave clinical medicine. There were the usual comments about going over to the ‘dark side’ and how industry physicians ended up there because they couldn’t do anything else. So I have to say that my biggest surprise was finding the level of honesty and quality among my peers.

I had to learn a lot about the business aspects of medicine, sticking to budgets and timelines, as well as the supportive science behind IND candidates and early phase trials. This was a bit foreign to what I had been doing as a clinician, but it came quickly to me. Finally, I had no idea about all the regulations. Now that I’ve been in the industry for a number of years, I feel like I have an understanding of drugs that very few physicians have in clinical medicine. As a clinician, I knew about what drug to prescribe for which indication and it’s various side effects, but I have to say I did not really understand drugs until I began working in industry.

BioPharm Physicians: You’ve worked in both large pharmaceutical companies and more entrepreneurial small pharmaceutical companies.  Can you describe some of the differences in the two environments?

Dr. Leach: Beyond the obvious differences (headcount, finances, size of the pipeline), I think that small companies don’t always fully understand their staffing needs for early stage clinical trials. In many cases, there is not enough work for a full-time physician, and hence it is more economical for small companies to find an experienced, part-time physician rather than to hire a more junior full-time physician. It’s also a good hedge during the period of greatest development risk. Small companies also need help managing their working relationships with the CRO to keep their program on track. Large companies generally know exactly what their needs are, often hiring temps during periods of intense work like NDAs or MAAs.

BioPharm Physicians: What advice would you give to a physician who is currently in a residency or fellowship program or a physician who is currently completing military service?  How should they think about the biopharmaceutical industry as a career option?

Dr. Leach: Medicine converges with basic science, statistics, business, government regulation and technology in the biopharmaceutical industry. It’s a good option for physicians with these broad interests, and who have the ability to operate in multidisciplinary teams. Registering a new drug is a rewarding experience but comes after many years of work, and often many setbacks. It may not be a great fit for physicians interested in primary care. While some industry physicians maintain a clinic, in my experience most of them give this up over time. Rarely do industry physicians leave to go back to clinical medicine so my sense is that most industry physicians do not regret their decisions to hang up their stethoscopes.

BioPharm Physicians: You are now an independent consultant for biotech and pharmaceutical companies.  What advice would you give to an industry physician who is currently employed in a pharmaceutical company and is curious about the life of a consultant?

Dr. Leach: Getting started as a consultant requires that you know a lot of people, and that they are familiar with your ability to solve a problem or get a job done. In Boston, there are a lot of biotech companies and there is a lot of turnover of personnel, so it is relatively easy for you to establish a reputation in a biotech hub. However, you must constantly prove yourself, and success requires that you always deliver on time and to the satisfaction of your client. I find I work harder as a consultant than I did as a full-time employee, but when you directly benefit from working harder, long hours aren’t really so long.

• Dr. Leach’s LinkedIn Profile

Routine medical monitoring requires periodic reviews of the clinical data. During the early stages of a clinical trial, the data should be monitored for signs that the investigators are enrolling appropriate patients and that they are capturing the data properly. For large, rapidly accruing phase III trials, data should be reviewed at least once a month. Early and periodic data reviews have the benefit of identifying problems with either the protocol or one of the trial sites. Early queries allow the sites to learn from their errors or omissions and prevent future mistakes. They also allow the data to be cleaned as the trial accrues, preventing a large number of queries being issued at the end of the trial, which could delay database lock.

But walking into the office only to see a thick stack of data listings on your desk is a depressing sight, so is there a better way?

In my opinion, static paper displays of data listings are a thing of the past, or at least they should be. The monotony of flipping through hundreds of pages of data, in a fixed sort order, can quickly lead your mind to drift, and a wandering mind makes it more difficult to interpret and assess the data.

So use that computer on your desk for something other than email. Stop flipping through reams of paper searching for only the data of interest when you can quickly find what you’re looking for with a few clicks of the mouse. Ask your biometrics group to provide the data as a spreadsheet. Moving data to a spreadsheet allows you to display only the data of interest, and to manipulate it to look for trends. The ability to electronically sort and filter data gives you a powerful method to monitor compliance with the protocol, identify data errors, and ensure coding consistency, among other things. It is much more efficient than reviewing paper listings. And once you find key data, you can quickly calculate descriptive statistics, histograms or more advanced analyses to summarize the data so that you can better understand it.

And don’t forget if you are using a CRO, it’s important that the provision of electronic data listings be a part of the scope of the contract.

Electronic review of data is an essential skill for the industry physician, and it can be easily learned, so why isn’t everybody doing it?

• Dr. Leach’s LinkedIn Profile