blog

To Post Doc or Not? – For Pharma

There have been several articles written about the value of a ‘post-doc‘ after completing a PhD. Nature reported that the number of post-docs increased 150% from 2000-2012. However, the number of available faculty positions hasn’t changed much. It’s a classic supply-demand problem. PharmDs are in a similar situation. The Pharmacy Times reported that the number of PharmD graduates was doubled from 2001-20015.

PhDs in Pharma

If you are a PhD professional in the pharmaceutical industry (pharma) or interested in building a career in pharma, one of the challenges you will discover is that on-the job training may not be what you expect. Most pharmaceutical companies will train new hires in two areas (1) pharma compliance and (2) disease state/product(s). There is little if any focus on training within functional domains.

The real value of a post-doc

The true value of a post-doc really is in the eye of the beholder. While there may be some who are against the value of a post-doc, it really depends on your career goals and objectives. If your goal is to work within research & development (Drug Discovery) within pharma, then there are certainly benefits to having more research experience. If you’re looking for a management consulting or medical affairs role, such as a medical science liaison, it becomes less relevant. In the purest sense, doing a post-doc does provides additional insight and depth but may make it more difficult to land a role later on in the job market.

How do you stand out?

Competition for pharma jobs is fierce. In particular, medical affairs has grown over 300% and will likely continue to grow as there is an increased shift towards specialty drugs, biologics, and rare/orphan diseases. This will increase the demand for more scientifically sophisticated pharma professionals who hold advanced scientific and clinical degrees.

Arming yourself with specialized training in the area you want to pursue certainly can help give you the specific skill set and knowledge to be more attractive to a prospective employer. Programs such as the Board Certified Medical Affairs Specialist (BCMAS) cover all areas relevant to medical affairs professionals in pharma, including medical science liaisons, medical information, health economics outcomes research and pharmacovigilance.

No alt text provided for this image

For most pharma jobs, a post-doc may not help. But it probably won’t hurt either. It really depends on your career goals as well as financial needs given the low salaries post-docs get.

For more information on the Accreditation Council for Medical Affairs. Visit us online.

Culture in Medical Affairs: Is your organization too focused on the “D” degree?

When reading many job postings, it is clear that the pharmaceutical industry and, more specifically, medical affairs departments are putting an increasing emphasis on the ‘D’ degree.  Doing so cuts out many highly qualified individuals.  Take Physician Assistants, Registered Nurses, or Pharmacists that have not returned to school to obtain their Pharm.D.  They do not qualify for these positions and will be overlooked by the Human Resources screener.  However, these particular professions often times possess the qualities necessary to become a successful MSL.

Doctorate level degrees certainly provide the scientific background needed to become a successful MSL, but that is only part of the story.  The MSL Society conducted a survey of medical affairs professionals as well as medical affairs managers in 2015 on Competencies that contribute most to MSL success. (ref)  A surprising finding from this survey was that scientific and technical expertise was the least important for driving business objectives.  With that said, focus on ‘D’ degrees places much more of an emphasis on this particular skill than this survey suggest should be allocated.  Instead, there are other skills that warrant more attention.

KOL management is a common job function of MSLs and often times a measure of success.  Being that Health Care Providers are becoming increasingly busy, each encounter must be more direct and productive.  Being an excellent communicator and delivering your message efficiently will most likely result in a follow-up encounter with the busy HCP.  In the same study conducted by the MSL Society (ref), it is suggested that being an ‘excellent communicator’ is the skill that matters most.  Interestingly, in the same survey, the MSL Society also found that this area is where MSL managers feel their MSLs are the least effective.  This skill is not something commonly taught in doctorate programs, it is something that is innate in an individual, or learned through experience.

The message that needs to be delivered is also an important factor and directly related to communications skills.  If a medication has a technical component to its delivery, the MSL must be able to convey the appropriate technique to the HCP.  For example, a medication utilized in the OR for post-operative pain control must be injected differently from routine practice in order to obtain the desired outcomes. Who is more qualified to deliver this message, an RN whose previous position was as a first assist nurse or a Pharm.D. whose previous experience is with an opioid pain reliever?  No question that both individuals are qualified, but who is more poised to deliver the message in the surgeon’s lingo?

Finally, experience should trump the degree.  The level of knowledge about industry-specific things like compliance, health economic, and KOL management is not something taught in Pharm.D. programs.  Additionally, many Medical Affairs professionals have been in their role since long before ‘D’ degrees became the norm.  Thinking about pharmacists specifically, an individual with a Masters in Pharmacy and 10 years experience as an MSL may be a better candidate than a Pharm.D. with 2 years experience as an MSL.

With the ever-changing landscape of Medical Affairs, less emphasis should be placed on the degree a candidate possesses.  More attention should be paid to drivers of success.  Specifically, communication skills, delivery of product-specific messaging, and experience are important factors that can predict success, and none of these skills are requirements for earning a doctorate level degree.

 

Written by Brian Faley, Pharm.D., BCPS

The Role of Medical Affairs from Research & Design to Commercialization

Bringing a new pharmaceutical product to market is a unique process based on a number of requirements for supporting a product launch. For a research and development (R&D) company, launching a product into market may seem to be an issue for someone else to handle in the far-distant future and at a much later time. But even at laboratory or early development stages, biotechnology companies should understand the language of pharmaceutical companies and know how that industry operates. Doing so helps biotech companies make early decisions regarding their investigational products that could lead to future success.

Here we focus on medical affairs, a critical part of the pharmaceutical industry. There is no real equivalent to medical affairs in biotechnology, yet it plays an ever-increasing and important role in that industry as well. A new and innovative way by which companies can use corporate partnerships to flexibly and efficiently maximize medical affairs support.

Background

The traditional bio-manufacturing model includes two main pillars: an R&D organization in charge of developing new products and a commercial organization in charge of marketing and selling those products. Pharmaceutical manufacturing has a similar split: a development group (responsible for getting FDA approval for drug products) and a commercial team (that markets and sells those products). One big difference, however, is that the bio pharmaceutical industry lacks an additional group to act as a bridge between development and commercialization. This is the role of medical affairs.

Medical affairs originally emerged as a reaction to increasing pressures from regulators to separate medical and commercial functions. Companies were experiencing increasing internal demands to focus the role of development on generating and developing new products rather than on managing products after FDA approval. Over the past 25 years, continued regulatory pressure shifted a number of commercial activities to people with medical expertise, most often to medical affairs groups.

Thus, medical affairs has evolved into a separate medical organization that often sits within development organizations but primarily works on post approval activities and has both the scientific and clinical expertise to support commercial products. Examples of medical affairs functions include:

·        Managing key thought-leader relationships

·        Publishing data from corporate-sponsored trials

·        Presenting educational information about a product or therapeutic landscape

·       Answering questions from healthcare providers regarding product safety or efficacy that is not addressed in a product’s label

·        Supporting research initiatives outside labeled indications for marketed products.

For a company whose product is years away from commercialization, the information above may be interesting, yet may seem irrelevant. It may be thought-provoking, but otherwise meaningless in day-to-day operations of a typical biotechnology company that is involved more with drug discovery than with drug development and commercialization. Although gaining a deep understanding of medical affairs may not seem immediately relevant, understanding the overall purpose of it and the functions it performs becomes crucial as a product moves closer to commercialization. Medical affairs can sometimes be overlooked due to competing priorities such as establishing a commercial organization, ensuring a smooth path toward regulatory approval, and creating and validating a stable and reliable manufacturing supply chain. However, a number of key medical affairs functions are critical at the time of product launch. The foundation for such functions must be laid 12–24 months before launch for this important department to deliver maximum value to a company.

Core Competencies

To illustrate that point, we must overview the three core medical affairs teams: medical communications/publications, medical science liaisons (MSLs), and medical information. We also discuss the ideal timing for implementing those efforts while preparing for a drug launch (defined as T0).

Medical communications/publications is a medical affairs group that directs and plans for all drug-related publications such as abstracts, posters, and manuscripts. Such communications are essential for product commercialization. The group is also responsible for developing a strategic plan that integrates and aligns the timing of clinical trial data locks with the release of key data points at scientific meetings. That plan outlines the timing of abstract submissions and defines when key manuscripts can and should be published in the years leading up to and following a launch. This includes publication of interim data (if available) for either early stage or pivotal trials, which can occur months to years before drug approval (T – 24 to T – 12; or 24 to 12 months before launch).

Another key role for a medical communications group is developing clear and consistent language to describe clinical results for the organization as a whole. A publication plan is even more critical after drug approval when a new product faces a competitive environment and medical communities begin to incorporate it into their therapeutic programs. Each initiative must be planned and carefully coordinated to maximize the amount of exposure, recognition, and buzz for a new drug product.

Medical Science Liaisons (MSLs) traditionally hold two main roles: to support a range of educational and/or research goals. But their real value, lies in scientific and clinical expertise that allows them to cultivate relationships with both external and internal parties. Externally, an MSL team is uniquely positioned as the “medical” face of the company in a way that is very distinct from its sales organization. It often has strong ties with both community and academic physicians and can be an effective conduit for a flow of information both out to a medical community and into a company itself. Internally, because of the bridge-like nature of medical affairs, an MSL team can use its strong relationships with other major corporate departments to help external parties understand and navigate internal waters. An MSL team is ideally formed sometime during the T – 24 to T – 12 time frame. That period provides time for mastering the disease state and therapeutic landscape, learning about all aspects of the drug, and — most important — establishing relationships with key external stakeholders (thought leaders, key organizations, and payers). It is essential for the success of a launch that those relationships already exist at T0.

Medical information experts are key resources within medical affairs for both MSL and commercial teams. A medical information group can address typical concerns about commercial drug products, including safety, efficacy, dosing, and administration. At the time of launch, medical information experts are often the primary recipients of questions from patients, healthcare providers, and other interested parties. So they must be equipped with fair and balanced, prewritten letters that accurately describe the information a company has available (or does not have) about each newly approved agent. In addition, medical information experts (or other representatives from medical affairs) play active roles in the development of commercial materials and/or sales training. Developing such materials is essential for preparing a commercial team for a product launch. The typical time frame for establishing a medical information group is the same as that of the other teams described herein (T – 24 to T – 12).

To maximize the value and effectiveness of medical affairs, this department should be formed about one to two years in advance of product launch. That period will allow a medical affairs team to become familiar with the product, understand related issues, and become experts in the group’s wide variety of roles and responsibilities. Understanding the capabilities and functions of medical affairs and the timing for when their functions are needed is a critical component of preparing for and executing a successful drug product launch.

10 Reasons to Work in Medical Affairs

  1. You get to impact patient lives on a macro-scale level.
  2. You use a wide variety of skills outside of your traditional training.
  3. You work with interdisciplinary team of professionals (MD, Ph.D., PharmD, NP, PA, DO, etc.)
  4. You will work with some of the top thought leaders in medicine, worldwide.
  5. Medical affairs has grown over 150% in the last 10 years & is estimated to grow another 200%. There are ample career opportunities.
  6. It’s anything but routine. If you like to mix things up, medical affairs is the perfect function for you. No one week is the same.
  7. You are the subject matter expert on a particular disease and become both a valuable resources and educator to your cross-functional partners who will rely on you as the “expert.”
  8. You’re always learning, growing and developing. As a medical affairs professional, you need to keep up with the latest & greatest in your particular therapeutic area.
  9. You can help influence the practice of medicine. For example, medical guidelines by providing appropriate & balanced education to the medical community.
  10. You gain a unique perspective on the healthcare landscape. And will deal with several facets of the healthcare system.

5 Reasons MSL Roles Are On The Rise

1. Healthcare Providers prefer to get their information from other ‘peers’

After training, Healthcare providers (HCPs) rely quite a bit on the pharmaceutical industry to provide important product & literature updates. As a matter of fact, 65% of research in medicine is driven by pharma. That said, several studies have shown that HCPs prefer information from other ‘peer like’ colleagues in pharma like MDs, PharmD, and Ph.D. professionals.

 

2. Today’s medicines are more complex.

There has been a significant shift to more specialized drugs. Biologics, personalized medicine, pharmacogenomics, artificial intelligence, digital health, and rare/orphan disease products are on the rise. Educating the medical community on these products requires professionals that have a strong clinical and/or scientific background.

 

3. Pharma industry liability will only increase.

2018 was the year of the ‘opioid crisis.’ And many pharmaceutical companies were right in the center of this firestorm. Companies like Purdue Pharma let sales reps go and relied more heavily on MSLs. Having professionals that provide more objective information minimizes risk to companies.

 

4. Physicians are not the only external stakeholder to pharma anymore.

The influence of stakeholders for pharma has expanded significantly. Payers, PBMs, regulatory KOLs, patient advocacy groups…well, you get the point… the list goes on and on…A thorough understanding of our complex health system (IDNs, ACOs, etc…) is needed coupled with a strong understanding of cross-functional groups in pharma. 

 

5. Access to healthcare providers is tougher than ever. 

Access to HCPs has gotten difficult. Physician reimbursement is lower. They value their time and need to see more patients, deal with more administrative hurdles and don’t want to waste time. Bringing a high level of value is key.

Top 5 Ways to Get Fired as a Medical Science Liaison

Outside of the typical reasons people get fired (ie., cheat on your expenses, falsify information on an application, etc…). There are 5 sure fire ways that you can get fired as an MSL.

 

1. Don’t know your science. 

If you don’t know the data, the value you bring to HCPs is minimal. Let’s face it, you’re the face of the company. If you make a bad first impression, it can be tough to bounce back. But it also causes a loss of confidence by your cross-functional colleagues (regulatory, sales, etc..) if they can’t rely on the ‘so-called’ subject matter experts.

 

2. Lie about your KTL/KOL interactions.

I once managed an MSL who flat out lied about seeing certain KOLs. They never had actually seen these KOLs but claimed they did. Sure enough, we eventually ran into these KOLs and it was apparent, they’d never interacted. We all know access is difficult, but use common sense and do the right thing.

 

3. Can’t balance the firewall properly. 

We know that a firewall exists between medical & sales. But I’ve seen cases where MSLs are outright demeaning to sales colleagues. Don’t do it. Remember, the sales & marketing teams generate revenue and help the company grow. Outside of it being just rude to do so, having too much of a firewall can alienate your cross-functional partners and make it difficult to coordinate effectively with KOLs/KTLs.

4. Poor presentation skills. 

As an MSL, being an effective presenter is key. You are often asked to present complex information to a wide variety of audiences. One negative presentation can strike a chord of insecurity about your abilities in your manager’s eyes.

5. Clueless about what the rest of medical affairs does and doesn’t do.

Don’t be too compartmentalized in what you do. Be sure to understand ALL of medical affairs (pubs planning, medical information, medical strategy, etc..). You will work with these colleagues closely. Broaden your skills, sharpen your knowledge and keep learning. Otherwise, it could mean a short-lived career.