May 23, 2017

Considering Pharma? Check out the DIA 2017!

pharma reseracherLast year was a big year for pharma at the Doctor’s Crossing. Four of my clients landed great jobs in pharma and I attended the inspiring world-renowned pharmaceutical conference – The DIA Global (DIA – Drug Information Association).

One of my four clients had no prior pharma experience and she is now working happily as a Drug Safety Officer for a large pharmaceutical company. She is proof that you can get into pharma without having experience in clinical trials or research. 

In my on-going efforts to learn more about pharma, scout for opportunities for clients, and get a better feel for the community, I attended the DIA’s annual conference in Philadelphia last year. I was one of 6,454 participants and I loved every minute. There was an electricity in the air which I attributed to being amongst so many bright individuals who are passionate about improving the health of patients in profound ways. Before I share specifics about the conference, I want to give you an idea of positions open to physicians in pharma.

  1. Drug Safety Officer  (Pharmacovigilance)– involved with reported side effects from drugs, labeling, SAE’s (serious adverse events). Can include involvement in preclinical studies. clinical trials and post-market stages. Public education.
  1. Medical Monitor – advises on clinical trials, planning, and implementation. Monitors patients enrolled in trials for safety, side effects and suitability for study enrollment and completion.
  1. Clinical Trial Researcher – participates in and oversees clinical trial design and implementation. Actively involved in running trials and design.
  1. Medical Affairs Director– bridge between drug development, marketing, and public education. Involved with medical information, communication, launch and post-market strategies.
  1. Medical Science Liaison –a knowledge expert in a therapeutic area, develops relationships with KOL’s (Key Opinion Leaders) externally, resource for physicians in practice; educational and communications role. Frequent travel.
  1. Medical Writer– prepares regulatory documents, slide decks, scientific articles, white papers, covers scientific and medical conferences, etc.
  1. Regulatory Affairs Director – knowledgeable about FDA regulations, prepares and submits regulatory documents, negotiates for market authorization for drugs and devices, keeps informed regarding legislative changes.
  1. Health Economics and Outcomes Researcher (HEOR) – concerned with the cost-effectiveness of drugs and devices, value, as well as the impact of treatments on patients.

 For a more complete description of these positions for physicians, please click HERE. (Note – the job opening links are no longer active).

Click HERE specifically for the Medial Science Liaison.

Sameer Thapar (PharmD), Director of Global Pharmacovigilance for Oracle, and one of the speakers at the DIA, shared a simple way to think about the complex array of jobs in pharma. He said, “There are the Makers, the Sellers, and the Defenders.”  The Medical Affairs and Medical Science Liaison positions help to bridge these three areas (my addition).

When considering a transition to pharma, you may wonder whether or not you would miss patient care and if you’d feel like you were making a difference in a meaningful way.

Dr. Kelly Curtis, my former client who now works remotely as a Medical Director and Medical Monitor for INC Research said this about his transition, “I find non-clinical work very rewarding and feel like I make more of an impact on the future of oncology in this role than when I was in academia.” 

I personally know a pediatrician who works remotely for pharma and he does a few pedi-urgent care shifts a month to keep his clinical connection to patients.  Although maintaining some degree of patient care while working in pharma is not the norm, some doctors find ways to do this through volunteering, medical trips abroad, or attending in a teaching setting.

The satisfaction from helping an individual patient can shift to helping entire populations of patients. Dr. Larry Brilliant, who gave the DIA 2016 Keynote address, recounted his fascinating involvement in eradicating smallpox and his on-going efforts to prevent and treat blindness in millions of individuals in developing countries. You can read about his amazing life’s work intertwined with his spiritual journey in his hard-to-put-down new book, Sometimes Brilliant

Here are some of the Hot Topics on tap for DIA 2017:

  • Data/Big Data/eHealth – informatics, data integration, bioethics
  • Disruptive Innovation – innovative science, technology and therapies: stem cells, regenerative therapies, gene therapies
  • Medical Affairs – MSL (medical science liaison), medical writing, medical affairs roles throughout product lifecycle
  • Patient Engagement – patient-centric practices, advocacy, culture, tools
  • Safety – best practices, post-market safety considerations, monitoring
  • Regulatory – advertising and promotional laws, regulatory writing, document management, compliance
  • Special Populations – Rare diseases, pediatrics, women’s health, aging
  • Preclinical and Clinical Development – discovery, clinical research, recruitment, clinical trial data disclosure, outcomes, statistics
  • Value and Access – drug pricing, reimbursement, access, real world outcomes

For additional information on the Hot Topics for DIA 2017 please click HERE.

For the Agenda for the DIA 2017 please click HERE.

I particularly enjoyed a panel presentation on “Big Data” with oncologist Dr. Brad Hirsch, CEO at SignalPath Research. Dr. Hirsch continues to see patients as well as work in pharma in the areas of informatics, innovation and gene-based therapies. You can tell he loves caring for his patients, and also being at the cutting edge of finding cures for the cancers that threaten their lives.

If you’re considering pharma, attending the DIA will give you a deep dive into this area, as well as the chance to make helpful networking connections. And your attendance would be an undeniable indication to any hiring authority of your genuine interest in this career direction. This is just one of a number of ways to increase your chances to land a pharma job.

Even though my time at the DIA was beyond busy, especially since I made a point to network at all of the exhibitor booths (pens anyone?), I left energized and uplifted. Call me pollyanna, but I felt that I was among a large group of people who really care about giving patients the chance for healthier and longer lives.  As physicians, and as individuals with loved ones, we know personally how devastating having an untreatable condition is, or having a poor quality of life due to illness. Pharmaceuticals are, of course, only part of the answer to good health, but when nothing else works, the right drug is truly a miracle.

The DIA 2017 will be in Chicago, June 18 – 22. 

 

 

 

 

 

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Dr. Laura McKain Shares Advice for Entering Pharma

larua mckain

Physicians play a multitude of roles in pharmaceutical development. Not all come from academia; many started out in clinical practice. I was in a private Ob/Gyn practice for a dozen years before I decided I wanted a change. I studied my options and decided to pursue a career in the pharmaceutical industry. The short story is that I was able to leverage some pharmaceutical consulting experience and professional connections into a position with a contract research organization, a company that conducts clinical trials on behalf of pharmaceutical companies. My current job encompasses a broad range of responsibilities: serving as the medical monitor for clinical trials, performing safety surveillance for clinical trials, working as part of a team developing new trials and even assisting business development in selling our services to future clients. The change from clinical practice has been a dramatic one for me (just what I wanted) and there has been a steep learning curve which has not yet plateaued, even after seven years! Every day brings new and exciting challenges. I love it.

Many of my colleagues have asked me how I made this transition. My own path was a winding one and would probably not serve as a map for anyone else. However, knowing what I now know, I can provide some practical advice and actionable steps that a physician can take to steer their career toward opportunities in pharmaceutical development. As you read these documents, remember that there were physicians involved in designing those studies, writing the protocols, training the physician investigators, conducting the trials, monitoring patient safety, and analyzing the data, writing the reports, and much, much more.

1. Learn about the clinical development process
A great first step in getting into clinical research is to learn as much as you can about the convoluted, arduous process of getting a new drug or to market. You are already familiar with clinical trials from reading medical journals, but keep in mind that those published papers are truly just summaries of the efficacy and safety data from one or a few clinical trials. To get a more in depth view into what an entire clinical development program looks like, the types and numbers of studies that are required prior to approval, and a better sense of the nitty gritty data that informed the published data, check out the regulatory reports that are produced with every new drug approval.

At Drugs@FDA.com http://www.accessdata.fda.gov/scripts/cder/drugsatfda/type in the name of a medication approved within the last 5 years ago. From the Drug Details page, click on the Approval History, Letters, Review, and Related Documents. There you will usually find the complete library of documents under Review as well as a slightly more compact Summary Review. Amongst the Review library, the Medical Review, is a terrific place to get the gory details on all the different clinical trials that were performed during that drug’s development. Look closely at the Sources of Clinical Data to get a “behind the scenes” look at the entire program.

2. Be an investigator
Acting as an investigator in industry sponsored clinical trials is the very best way to gain translatable pharmaceutical industry experience. You gain a working knowledge of the pharmaceutical development process that can be leveraged into other work in the industry. You don’t have to be in academics or working at a pharmaceutical company to do this. As a physician in clinical practice, you have this potential as well. Participating in clinical studies with your patients can be a part-time endeavor and be a great break from the routine of seeing patients. Some physicians make clinical research their full time job and run their own clinical research facilities or work for one. All agree that it is immeasurable satisfying to contribute to the development of new treatments for patients.

As an investigator you spend time assessing whether a patient meets the entry criteria for a trial. It is your responsibility to explain the trial to the patient and get their consent. Once a patient is entered into the study you see the patient periodically to assess whether the study drug is working and whether there are any adverse reactions that might be related to the study drug. You have to keep immaculate records on all of this work and will interact with study monitors who will visit to ensure you are adhering to the protocol and are accurately reporting the data. You will have access to a medical monitor, (another great industry job for physicians) who will serve as a resource person for questions about executing the trial. You may also have to answer to the medical monitor if you deviate from the protocol.

It can be really hard to get your first gig as an investigator since most pharmaceutical companies prefer to work with physicians who are experienced. One way to get your foot in the door is to act as a sub-investigator to a principal investigator in a clinical trial. As a sub-investigator you may be delegated to perform the duties of the principal investigator, particularly when the principal investigator is not available. Sub-investigators usually get paid but, if you really want to get your foot in the door, you could consider volunteering to fulfill this role for a trial or two in order to build your CV. Read on to get ideas on where to find opportunities as an investigator.

3. Check out who is performing clinical research in your area.
Find out what type of clinical trials are going on right now, particularly in your area. Go to https://clinicaltrials.gov and type in the name of conditions you commonly take care of to see which companies are developing products, what trials they are doing, and where the trials are being conducted. Look for trials in your geographic vicinity and reach out to the investigative sites for more information. This is a great networking opportunity. Talk to the principal investigator about the studies and their work. Do you have patients that may benefit from an opportunity to receive a new, cutting-edge treatment for their condition? Consider referring patients to the study and keep in touch with the investigator and your patient’s progress. Express interest in the clinical trial process. Terrific insights and connections can come from this!

4. Reach out to a Site Management Organization (SMO)
There are commercial enterprises known as SMOs that provide the infrastructure including: contracting, staffing, training, and patient recruitment for clinical trials. The companies create networks of clinical research sites so they can efficiently offer trial sponsors immediate access to a large population of potential patients. SMOs often are looking for physicians to act as principal investigators for clinical trials they perform for pharmaceutical companies. They may have their own physical site where they conduct trials or they may even provide the infrastructure so you can conduct trials at your workplace. Again, these companies are a great way to make connections and find opportunities to gain experience in clinical research.

5. Talk to the pharmaceutical sales representatives that visit your office
You may think that pharmaceutical sales representatives are just salesmen who want to persuade you to use their drug. Technically, they are, but as part of their training they amass an amazing fund of knowledge on how the drugs they sell were developed. They also know what their company has in the pipeline because their job security depends on having something new to sell. These reps may be great resources for inside information and connections back at their mothership. They may be able to put you in touch with people at their company who organize clinical research or with medical science liaisons who could be the gateway to educational positions with their company (think speakers bureau) or other opportunities.

6. Get some formal training
Every physician who works in clinical research must have formal training on the International Conference on Harmonization (ICH) Guidelines for Good Clinical Practices (GCP), the globally recognized standard for the conduct of clinical trials. Basically, these are the rules for ensuring that the rights and safety of clinical trial subjects are protected. You simply must have GCP training on your CV if you want to work in the industry. Happily, you can take online courses to get this training. Many are offered by commercial providers that charge a fee, but there are also excellent courses that provide training at no cost.

I recommend checking out the National Institute of Allergy and Infectious Diseases/National Institute of Health GCP Course. You don’t have to be an NIH user to take this course. You can sign in with a Google Account. Another good course to check out is the NIH Protecting Human Research Participants Course, which is also offered for free. This has great information in short modules that you can knock out one or two at a time plus you get a certificate when you finish. Again, these are actions you can take to build knowledge and experience to work in pharmaceutical development. Without some type of industry experience on your CV, it is very difficult to get your foot in the door. You don’t have to be an academician to transition to the pharmaceutical industry!

7. Network!
Look for opportunities to meet physicians already working in the pharmaceutical industry. The next time you attend a medical conference spend some time in the exhibition hall and visit some of the industry sponsored booths. You will often find physicians who work in the medical affairs department staffing those booths. Invite one for a cup of coffee and find out what they do. If you become an investigator and get to attend an investigator meeting to learn about the protocol, seek out the medical monitor and be sure to sit with them at breakfast and lunch and pick their brain. If you really want to immerse yourself in industry think about attending a conference like the annual Drug Information Association (DIA). You will find physicians from every single facet of industry there, including the FDA. There are countless formal and informal opportunities to meet and greet at a venue you like that. And of course LinkedIn is a great resource and you don’t have to leave home. The value of the connections, advice, an influence gained from networking is simply priceless.

Dr. Laura McKain is an Ob/gyn physician with extensive experience in the pharmaceutical industry. She currently works for PPD in pharmacogvigilence. Thank you kindly, Dr. McKain, for offering to write this great post for The Doctor’s Crossing.