Rho site logo

Rho Knows Clinical Research Services

Update from the top: FDA’s Office of New Drugs ongoing reorganization process

Posted by Karl Whitney on Thu, Jan 02, 2020 @ 11:00 AM
Share:

karlKarl Whitney, PhD, RAC, Assistant Vice President of Product Development, leads multiple integrated drug development programs spanning the development spectrum by planning, managing, and overseeing concurrent manufacturing, nonclinical, clinical, and regulatory activities.

Rho representatives joined regulators, industry scientists, and numerous patient-advocacy groups at CBI's Rare Disease Clinical Development & Access conference in Washington 03-04DEC 2019. During an opening plenary session, FDA's Office of New Drugs (OND) director Dr. Peter Stein shared comments and took questions from the audience. Participants asked a number of questions that indicate a high degree of interest in (and, perhaps, some anxiety about) OND's ongoing reorganization in general and as it might affect specific current projects at the IND or NDA review stage. This reorganization was announced earlier in 2019 and will, among other things, increase the number of offices overseeing review divisions from 6 to 8, and split and/or redesign review divisions to increase the number of divisions from 19 to 27. The reorganization is being implemented in four phases, with the last set to complete by February 2020. Dr. Stein certainly attempted to address some of the audience's concerns. His key message: the ongoing reorganization is intended to improve review processes while ensuring continuity for individual projects. In short, FDA doesn't want to fix what ain't broke.

Instead, the overall goals are to establish more therapeutically aligned, integrated review teams that take an interdisciplinary and 'problem-focused' approach to reviews; and to modernize and standardize review processes across divisions. In the process, he and hOptimization - Business Concept. Golden Compass Needle on a Black Field Pointing to the Word Optimization. 3D Render.is team are taking great care to ensure OND operates smoothly, and that review teams have a re-energized scientific focus for their work.

On the former, he hopes the reorganization will make for more sensible Division groupings. Some large divisions such as Neurology or GI/inborn errors are being split up so that Division Leadership can spend more time on the science and be more externally facing  (eg, at conferences). Individual review teams are being kept together as much as possible when these new divisional groupings are being designed. Further, he has instructed Division heads overall to avoid revisiting prior agreements made between the sponsor and the review team if the team has moved divisions. He believes strongly that it's in nobody's interest to upend established agreements, though he reminded the audience that of course, FDA reserves the right to update its positions as new data accrue. So, sponsor caveat emptor.

On the latter, OND is trying to enhance reviewer consistency and throughput by using a new review template and improved processes that support efficient, integrated reviews of submissions from IND through to approval/post-approval. In addition, a new non-review office called Office of New Drug Policy has been established to support review teams when novel Orange Business Processes Button on Computer Keyboard. Internet Concept.issues come up that lack clear guiding precedent, so that review teams across the OND approach novel issues with greater consistency. Another new cross-cutting office of interest to conference attendees is the planned Division of Rare Disease and Medical Genetics within the new Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine. This group will not have direct review responsibilities but rather will offer 'consultative support' to help review teams properly exercise 'flexibility' in product development programs for example in terms of expected safety database size, a topic that commonly arises, naturally, with rare disease development programs. These rare-disease sponsor projects will still be overseen by the Division that makes the most sense from a therapeutic area - for example, Division of Anti-infectives. The new Division of Rare Disease and Medical Genetics group will also have a mandate to engage outside FDA with patient groups, other regulatory bodies, academia, and even Advisory Committees to ensure they understand realities for rare disease product development. One can only speculate as to why these new responsibilities were not assigned to the longstanding Office of Orphan Product Development.

Overall, the audience took a wait-and-see approach insofar as the reorganization is ongoing and the chips haven't fallen yet. Time will tell if the major goals of the reorganization are achieved by this structure, but Dr. Stein certainly made his best case for the various rationales for the temporary upheaval. Maybe spring cleaning came a bit early to the OND this year....

 

Is a Target Product Profile Worth the Effort?

Posted by David Shoemaker on Wed, Dec 18, 2019 @ 09:32 AM
Share:

David2

David Shoemaker, PhD, SVP R&D, has over 25 years of experience in pharmaceutical product development. He has served as a Program Leader or Advisor for multi-disciplinary program teams and has been involved with ensuring products meet regulatory standards at all stages of the development process.

A recent study by the MIT Sloan School of Management determined only 14 percent of clinical studies succeed, indicating there is room for vast improvement in the pharmaceutical industry’s ability to develop needed therapeutics more efficiently1. Inasmuch as the clinical develop program for a product comprises several to dozens of clinical studies to achieve marketing approval, chances are that one or more studies will fail during development. Coincidentally, this success rate of 14 percent approximates the age-old estimate that 10 to 20 percent of products that enter human studies make it to the market2,3. However, an eventual failure rate of 80 to 90 percent for products entering Phase 1 speaks to more than simply clinical study failure rate. The failure rate indicates an overall development process shortcoming that begins during the preclinical stage and destines product development programs for failure. This is due in part to the fact that companies are in many cases not doing the correct clinical study on an efficient path to marketing a needed therapeutic product. They do not possess a road map for success.

As a contract research organization who works extensively with late stage development companies collaborating on the preparation of their marketing applications, Rho continually observes product sponsors who fail during late stage development due to preventable missteps with their product development program. We are always buoyed by starting a new relationship with a company who has taken the time to prepare a Target Product Profile (TPP) because we know we have a client who understands the importance that prescribing information and market position play in the ultimate approval of a product by the regulatory authorities and the commensurate successful market capture. Simply achieving marketing approval is not the goal. The goal is to provide a useful therapy that will meet the needs of patients, physicians, and payers and hopefully advance current therapeutic options. The TPP provides a road map for development of a product, laying out all the key development performance criteria that the investigational product must meet in order to ultimately become the useful therapy the sponsor wants it to be; failure to meet any of these key criteria means the investigational product will not succeed as a useful marketed product and development should be abandoned or somehow re-engineered.

The crafting of a TPP is enabled by a detailed understanding of not only the disease and its associated market, but also unmet patient, physician and payer needs. The goal posts for each of the stakeholders need to be determined by identifying the minimal and the optimal characteristics for a variety of TPP elements. The major criteria to meet patients’ needs reside primarily in efficacy and safety elements, but satisfying dosage, route of administration, and specific patient reported outcomes also must be considered. Obviously physicians’ primary needs will be met if the patients are satisfied but there may be additional considerations regarding route of administration as well as ease and efficiency of therapy. Payer value is derived from beneficial differentiation of efficacy and safety but there may also be differential market forces to consider based on geographical regions (e.g., free market, US; clinical effectiveness, France and Germany; cost effectiveness, UK and Canada). If it becomes clear at any point in development that you will fail to meet the minimal criteria for your product to satisfy any one of these stakeholders’ regulatory or commercial requirements, a company is well advised to abandon development. Also, it is simply common sense for companies to Data analysis chart and graphs-2identify their principal competitive product on the market as well as potential competitive products in development prior beginning their development program in earnest. A comprehensive TPP should contain all of these elements.

The organization of the TPP is understandably varied across the industry with some people using the US Prescribing Information as a template and others adopting the European Summary of Product Characteristics. The FDA even issued guidance back in 2007 advocating the use of the US Prescribing Information organization (https://www.fda.gov/media/72566/download). The advantages of these strategies include the fact that you are effectively preparing your US annotated package insert during your development plan. These documents help both with minimizing and focusing development activities and organizing your marketing application, and they are in a format optimal for discussions with regulators. However, a complete TPP should still include an independent payer assessment that is of no interest to regulators. Other companies prefer more general categories than are found in product labeling such as efficacy, safety, payer value, dosage, indication, population and juxtapose these elements with the attributes of their target competitive product for a more commercially oriented TPP. This allows one to easily see when your product comes up short against a competitor thereby rendering a course correction or a No Go decision.

By focusing both the developmental and marketing goals in the TPP at the preclinical stage a company is able to build a commercial differentiation strategy into their early development plan. Preclinical studies are a lot less expensive to conduct than clinical studies and hypotheses can be tested versus competitive products efficiently. These preclinical experiments may or may not lead to earlier examination of active comparator studies in the clinic. However, it will most certainly enforce the understanding that validating a novel mechanism of action is less important than clinical differentiation from a competitive product. These experiments may allow a company to distinguish between competitors and identify the key competitive product to compete against. Demonstrating proof of concept in no way guarantees profit on return, so it is imperative that companies explore pharmacodynamic activity versus competitive products in their preclinical development programs.

A common reason small or inexperienced companies do not prepare a TPP is the proposed cost and amount of time that must be devoted to its preparation. Companies with an exit strategy at proof of concept or prior to phase 3 often claim the cost is not justifiable. However, the value created by a well-run development program that checks all the boxes for an intelligent investor is worth much more than the cost invested in the preparation of the TPP. Investment firms and big pharma are primarily looking for investments where the risks have been minimized and a program that has been conducted efficiently focusing on the ultimate appropriate indication and patient population while examining carefully the commercial landscape holds enormous value.

Perhaps the greatest value of the TPP is as a communication tool. The ultimate goal of the communications-networkdevelopment program is shared clearly and continually with all the company disciplines, e.g., clinical, preclinical, chemistry manufacturing and controls, regulatory, and marketing. The TPP is also able to be used as an external communication tool that facilitates interactions with regulatory authorities, investors, and the media. The document can be used to help structure regulatory and investor briefing documents as well as press releases. The TPP’s additional use as a communication tool is as an educational document for new team members whether they are within the company or at regulatory authorities.

The bottom line is, you must prepare a TPP early and revise it continually during development if you wish to bring a successful therapeutic to market to advance patient treatment or you are left relying on nothing more than good fortune.

1 Wong, C.H, Siah, K.W., and Lo, A.W. Biostatistics. 2019; 20(2): 273 – 286.
2 https://www.reuters.com/article/us-pharmaceuticals-success/success-rates-for-experimental-drugs-falls-study-idUSTRE71D2U920110214
3 https://www.policymed.com/2014/12/a-tough-road-cost-to-develop-one-new-drug-is-26-billion-approval-rate-for-drugs-entering-clinical-de.html

 

Orphan Drugs and Single Trials

Posted by Joseph Watson on Thu, Dec 12, 2019 @ 09:00 AM
Share:

Joseph Watson, PhD, RAC, Research Scientist at Rho, has experience in both regulatory submissions and clinical document preparation, with over fifteen years of experience in scientific writing and editing jwatsonclinical and nonclinical documents, including numerous publications in peer-reviewed journals.  Dr. Watson has led the preparation, review, and coordination of a variety of regulatory and clinical documents, including protocols; clinical study reports; integrated summaries of biopharmaceutics, safety, and efficacy; CMC and nonclinical documents; draft product labels; and 120‑day safety updates.  His writing and editing experience covers a broad range of therapeutic areas, including drug addiction, middle ear disorders, infectious diseases, psychiatric disorders, acute and chronic pain, multiple sclerosis, hemophilia, and oncology. 

Since the enactment of the Orphan Drug Act in 1983, the number of orphan drug approvals has risen steadily. In 2018 alone, 34 out of 59 approved novel medications were for orphan diseases. Consistent with the increase in orphan applications reviewed by the Agency, Rho has received an increasing number of sponsor requests for support of programs working towards an orphan drug approval. Our sponsors often think that their product can be approved with support from a single trial, but how realistic is this stance? To better understand when a single trial approval is possible, we look to FDA guidances.Conceptual image with ladder reaching increasing graph-1

In the 1998 Guidance for Industry Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products, FDA spells out the potential circumstances in which a single clinical trial for a novel therapeutic could be sufficient to support an efficacy claim. The guidance states “reliance on only a single study will generally be limited to situations in which a trial has demonstrated a clinically meaningful effect on mortality, irreversible morbidity, or prevention of a disease with potentially serious outcome and confirmation of the result in a second trial would be practically or ethically impossible.”

The key points outlined in the guidance are:

1.   The condition must be serious. If the FDA doesn’t believe the condition is serious, they will not consider a single adequate and well controlled trial for a novel therapy.
2.   A second adequate and well-controlled trial is practically or ethically impossible to conduct. This situation could apply for an orphan indication given limited patient populations (and likely assuming point 1 above).

Both points could apply to an orphan indication; an orphan indication has, by definition, a limited patient population, and many orphan indications are serious. A serious orphan indication falls into the “sweet spot” in which FDA may be willing to show flexibility and accept a single adequate and well-controlled trial.

After considering points 1 and 2 below, FDA must review the single adequate and well controlled trial to determine if it is sufficiently robust and compelling; i.e., does it feature any of 5 characteristics that could make it adequate to support an effectiveness claim (in other words, sufficiently robust & persuasive; FDA’s typical prior to reviewing the data is that the determination will be a review issue):

1.   A large multicenter study
2.   Consistency across study subsets (large trial)
3.   Multiple studies in a single study (e.g., properly designed factorial studies)
4.   Multiple endpoints involving different events (i.e., prospectively identified primary and  secondary endpoints representing different beneficial effects)
5.   Statistically very persuasive findings

For orphan indications, characteristics 1 and 2 are difficult to achieve due to the need for large trials. Characteristic 3 is situational; the example provided by FDA highlights a combination therapy tested as both the combination and as individual parts. Characteristic 4 is typically incorporated into the study designs Rho reviews. Often, this item can be interpreted by sponsors as the “everything but the kitchen sink” approach. In our experience, multiple well thought out, differentiated endpoints can help FDA assess approvability; however, FDA will stress that these endpoints should be independent of each other.

Additionally, FDA will often request that the endpoints be hierarchically ranked; this preserves the overall alpha for the study by preventing companies from fishing for an acceptable endpoint should the primary fail. If the program hits on multiple, well-thought out, agreed upon endpoints, improves significantly on current therapies, and the disease is serious, FDA may consider a single trial appropriate.

Clinical Trial written in search barCharacteristic 5 is likely the most realistic situation orphan drug sponsors can achieve, in spite of the small sample sizes typically observed in orphan trials. Assuming the orphan indication is for a serious indication (as defined above), FDA will at times negotiate with a sponsor those outcomes considered sufficient to support approval with a single clinical trial. Such a strategy should be discussed prospectively with FDA prior to initiating the pivotal trial; assuming FDA agrees with the design, FDA may be willing to consider allowing the filing to proceed if either 1) a highly statistically persuasive and clinically meaningful outcome is achieved or 2) at FDA’s discretion, dependent on FDA’s review of the efficacy data, the severity of the disease, and medical need. In practice, this approach has a high chance of failure, as most companies who work on orphan products move into their pivotal study with either 1) very small proof of concept Phase 1/2 trials that hint at efficacy but are not robust or 2) uncontrolled Phase 2 studies that show efficacy versus natural history data but fail to achieve statistically significant results when conducted as randomized, double-blind studies.

That aside, recently, FDA has taken an active approach for approving products based on a single trial with certain therapeutic paths, particularly anti-infectives. The Limited Population Antibacterial Drug (LPAD) pathway allows antibiotics to be approved and labeled for small populations with unmet needs. As of October 2019, two products have been approved using this pathway with single clinical studies:

•   Arikayce (amikacin liposome inhalation suspension), for the treatment of lung disease caused by a group of bacteria, Mycobacterium avium complex, in a limited population of patients with the disease who do not respond to conventional treatment, approved with a single trial on a surrogate endpoint (sputum conversion); and
•   Pretomanid Tablets in combination with bedaquiline and linezolid for the treatment of a specific type of highly treatment-resistant tuberculosis of the lungs, which was approved with a single trial that showed significant benefit relative to historical controls.

The success of these programs demonstrates FDA’s willingness to be flexible when the benefit can be properly assessed and truly outweighs the risk in a specific patient population. However, companies should be cautious when developing an orphan product. Prospectively planning to properly assess efficacy outcomes in reasonably sized, randomized, double-blind Phase 2 trials will help companies make appropriate go/no go decisions earlier in a product’s life cycle, ultimately helping companies spend less time and money on unapprovable products.

North American Cystic Fibrosis Conference: Key Takeaways

Posted by Lisa Payne on Thu, Dec 05, 2019 @ 09:00 AM
Share:

The 33rd Annual NACF conference continues to be an action packed 3 days bringing together scientists, clinicians, health care providers, and caregivers to discuss the latest advances in CF research, care, and drug development.  These are our top 3 takeaways from the meeting and how they will impact clinical research moving forward.

We’ve come a long way, baby.

In the plenary talk on the first day, Marie Egan, M.D., provided an important overview of how far CF research has come over the past 30 years in her talk, “Emerging Technologies for CFTR Restoration in All People with CF”. This talk highlighted innovative technologies, including RNA therapies, gene therapies, and gene editing technology that hold potential to finding a cure. Dr. Egan also discussed the challenges and opportunities presented by these novel therapies as they advance toward the clinical study phases of development. Some of these challenges are very similar to what other rare disease communities are facing as the research of gene therapies increases. For clinical research, recruitment and retention in these trials (that can have a follow-up time of at least 5 years) need to be broached carefully, so participants understand the potential benefits and risks that await.

Excitement around Trikafta approval.

A week and a half before the conference, FDA’s approval of Vertex’s Trikafta was announced. With this approval, 90% of the CF community have a treatment option, which is an outstanding achievement. There was excitement around the approval and what this means to those with CF. What we are hearing from sites is that this also means ongoing clinical research studies are likely to have some delayed enrollment as patients start taking Trikafta. The delay will typically be the result of getting on to a stable dose to meet inclusion criteria, in addition to reduced resources at the site, as more patients are requesting appointments to switch onto Trikafta.

Medical News on Multicolor Puzzle on White Background.In the second plenary, Jane Davies, MD, MBChB, MRCP outlined the progress and promise of highly effective CFTR modulator therapies and the potential impact that Trikafta could have on this population. Whilst celebrating the success of effective modulator therapy, Dr. Davies also discussed challenges that remain, including treatments for people with rare mutations, caring for a patient population that has grown and aged, and providing access to CFTR modulators in more regions of the world.

CFTR modulators are not expected to eliminate the need for additional chronic therapies and drugs. While there is potential that CFTR modulators offer an opportunity to restore function earlier in life and alleviate a lifetime of lung damage that patients fight into adulthood, patients and families have expressed that reducing the treatment burden is a high priority and even patients on effective modulator therapies are not commonly reducing their other treatments. So while daily care has become increasingly effective, it remains complex and burdensome. This highlights the need for additional treatments and a cure for those with CF.

We will not stop until CF stands for Cure Found.

Current NIH director Francis Collins and his team helped discover the cystic fibrosis gene and he emphasized that the recent approval of Trikafta means that 90% of the community have the potential to receive a remarkable treatment; however, there are still patients with CF who might not benefit from this new therapy (including individuals with rare and nonsense mutations) and we must not abandon the 10% of people for whom these drugs will not provide benefit. Work towards finding a cure for all is just getting started.

A new era in CF research is beginning. The CF Foundation recently unveiled the “Path to a Cure” initiative, which will focus on finding treatments for the underlying cause of CF and a cure for every person with CF. The CFF is challenging academia and industry to accelerate progress in CF drug discovery and development. To help this ambitious initiative, the foundation intends to allocate $500 million to the effort through 2025.

This new era means that other recruitment strategies and study designs should be considered to enroll and execute a successful trial. Understanding the new patient population will be critical, and will require being cognizant that the baseline disease severity will vary across the population. New clinical trials in the era of modulator therapy may also require new endpoints,Medicine doctor hand working with modern computer interface as medical concept-1 as incidence or severity of common endpoints such as pulmonary exacerbations may change. Innovative study designs should be considered, but will require an increased amount of regulatory interaction.

Despite this remarkable progress there are significant needs that remain. As the CFF president and CEO, Preston W. Campbell, III, M.D, stated “Don’t stop dreaming of a day when all people with CF can say, ‘I used to have CF’.” Prioritizing innovative approaches to find a cure is at the forefront of the CFF’s mind and a recurring theme at the conference was the sentiment that the most important and challenging work lies ahead – until CF stands for Cure Found.

Need support designing and executing your next CF trial? Ask our experts for help.

JamieA3Jamie Arnott, RN, BSN, OCN®, Rho Project Director, received her undergraduate degree in Nursing from the University of North Carolina at Chapel Hill.  She has extensive experience from both the CRO and sponsor perspectives in the oversight and management of clinical trial operations and outsourcing with more than 12 years’ experience in project management and over 20 years’ experience in healthcare as a practitioner and manager.  Prior to her tenure at Rho, Ms. Arnott was the Director of Clinical Trial Operations for a biotechnology company where she provided oversight and management for all clinical activity for up to four concurrent INDs.  Ms. Arnott has broad therapeutic experience with ENT indications, cystic fibrosis, and multiple oncology indications, including ovarian cancer, hematological malignancies, and advanced solid tumors; she has pediatric experience both within the oncology field as well as orphan diseases. 

Kristin Gabor-2-1Kristin Gabor, PhD, RAC, Research Scientist, has over a decade of experience in writing and editing scientific documents and publications across a variety of biological, clinical, and regulatory fields, which includes several publications in peer-reviewed scientific journals.  Dr. Gabor has led and participated in the authoring and preparation of clinical study reports, clinical protocols, annual safety reports, modules of regulatory submissions (NDA, IND, etc.), and other regulatory documents in a variety of therapeutic areas.  She has also coordinated document review for regulatory submissions and led the management of safety review committees for clinical studies.  She has experience in a broad range of therapeutic areas, including sickle cell disease, allergy, inflammation, and immunology, infectious diseases, rare diseases, atopic dermatitis, multiple sclerosis, and cystic fibrosis.  Dr. Gabor earned an interdisciplinary PhD in Functional Genomics from the University of Maine and subsequently received an Intramural Research Training award from the NIH/NIEHS for her postdoctoral studies investigating the role of cholesterol metabolism and cell membrane perturbations in regulating the innate immune response in a rare genetic disease.  Dr. Gabor received her Regulatory Affairs Certification from the Regulatory Affairs Professionals Society (RAPS) in 2018 and is a current member of RAPS and the North Carolina Regulatory Affairs Forum (NCRAF).

NancyWsmallNancy Woody, MA, PMP, Senior Project Manager, has over eight years of project management experience in a clinical research organization (CRO) supporting and leading Phase 1 through 4 global and regional trials. Prior to working at Rho, Ms. Woody worked primarily on late phase and real-world evidence research studies and the collection of patient outcomes in standard of care settings and existing data sources. She has provided leadership to cross-functional clinical research projects and teams, virtually and co-located, in a wide variety of indications including Rare Disease (cystic fibrosis), CNS (Alzheimer’s, Multiple Sclerosis, spine pain, women’s pain, etc.), endocrinology (Diabetes) and oncology (Multiple Myeloma). As the project manager, Ms. Woody’s responsibilities include the creation and maintenance of project management plans, advising on operational strategies and mitigation plans, close collaboration with sponsor contact, and management of vendors, study team resources, timelines and budgets. She has a background in intercultural training and conflict resolution, which has helped to inform her work in risk management and mitigation on complex trials and within diverse teams. Ms. Woody is a certified Project Management Professional and received her Master’s degree in Intercultural Relations from Lesley University and a B.A. in Communication Studies from the University of North Carolina at Chapel Hill.

Collaboration versus Concentration: The Office

Posted by Brook White on Wed, Nov 07, 2018 @ 09:47 AM
Share:

Quick quiz for fans of The Office: Can you remember where each employee sat in the Scranton Dunder Mifflin office?  Even if you can’t get it perfect, chances are you can close your eyes and envision the layout.  The office was open with very few physical boundaries between desks.  Employees could see each other face-to-face and hear one another at all times.  It was a set deliberately configured to create the awkward interactions and comedic conflict that made the series so popular.  The design was perfect for sitcom parody, but it was disastrous for productivity.  

The open office concept has gained popularity in recent years, even becoming a sort of corporate status symbol suggesting that a company values openness, collaboration, and innovation.  However, recent research suggests the open office has the exact opposite effect on employees – reducing in-person interactions, driving up email and IM use, and diminishing productivity.  Several reasons have been given for these results, including: offices are too noisy and distracting, employees feel a loss of privacy and more stress, and individuals prioritize “looking busy” over doing impactful work.  

To quote Michael Scott, “We don’t hate it.  We just don’t like it at all, and it’s terrible.”

deep work, concentrationThe problem is not that having places of open collaboration are bad, it’s that an office cannot be constructed around this virtue alone.  Employees also need time for distraction-free, heads-down, concentration work.  In Deep Work, Cal Newport praises an alternative layout that maximizes the benefits of both “serendipitous encounters and isolated deep thinking,” which he dubs a hub-and-spoke design.  The concept is simple: have quiet personal areas of working that minimize distraction and interruption that are connected to large common areas that facilitate teamwork, mutual inspiration, brainstorming, and idea sharing.  

We took these lessons to heart when designing our new office space.  

collaboration and team workThe upper floors, which will house most employees’ work spaces, are built around the hub-and-spoke design.  Collaboration spaces (conference rooms, war rooms, huddle rooms, the pantry) are centrally located with cubes and offices spreading out from there.  Within the individual workspace areas, we alternate rows of cubes and offices which will dampen sound and prevent large areas of noisy cubes.  We are also providing more spaces for quiet concentration away from your desk with Focus Rooms, offices equipped with treadmill desks for shared use, and Libraries.  On the first floor, in addition to the main conference room suite, there will be more opportunities for collaboration with a much larger Hub and adjoining Game Room, and larger Patio.

We are really excited about the new space, but at the end of the day, it is still just an office.  A building doesn’t make us special.  Our employees do.  The best our physical workspace can do is provide a structure conducive to good work, but the onus is on each of us to adopt and implement productive behaviors.  

A primary goal of our new headquarters is to build a workspace that makes people excited about where they work.  We look forward to seeing how the move to the new building supports Deep Work and improves our collective productivity.

Ryan2Ryan Bailey, MA is a Senior Clinical Researcher at Rho.  He has over 10 years of experience conducting multicenter asthma research studies, including the Inner City Asthma Consortium (ICAC) and the Community Healthcare for Asthma Management and Prevention of Symptoms (CHAMPS) project.  Ryan is also part of the team at Rho that encourages and facilitates Deep Work.

Culture Fit Interviews: What Are They and Why Do We Do Them?

Posted by Brook White on Tue, Jul 17, 2018 @ 09:53 AM
Share:

If you’ve ever interviewed for a job at Rho, you know that one part of our process is a little different from what many other companies do.  Each prospective employee goes through a culture fit interview.  So, what is a culture fit interview? (And equally important, what isn’t a culture fit interview?)  Why do we think they are important?

What it is

Rho team  members Liz, Daniel, and SeanThe purpose of the culture fit interview is to make sure that each employee we bring on board shares and embodies the same values that we do.  You can read more about our core values here.  These interviews are conducted by a select set of senior leaders who have been with the company for quite a while.  The interviews do not assess skills or technical qualifications, and, generally speaking, won’t be performed by someone who shares the same expertise as you do.

We use the same bank of questions for all culture fit interviews whether you are applying for an entry level position straight out of college or a senior leadership position.  These questions ask for examples or stories from your past experience that assess qualities that we think are important—ability to work as part of a team, to think critically and creatively when solving problems, to communicate effectively, and  to demonstrate integrity.

What it isn’t

We recognize that one of the dangers of this type of screening is that it provides an opportunity to weed out candidates that aren’t “just like us.”  That is not what we are doing.  We value diversity of all kinds—demographic diversity, diversity of experience, and diversity of perspective.  We are not looking to create a homogeneous workplace where everyone thinks and acts the same.  

We are, however, looking to select candidates that can succeed and thrive in our workplace.  From experience, we’ve identified some of the attributes that can make otherwise similar candidates succeed or fail at Rho.  There are people who are highly skilled and who can be highly successful in other corporate climates who won’t do well here.  We owe it to them and the people who would work with them to try and identify them ahead of time.

In addition to the qualities listed above, there are aspects of our environment that can cause otherwise successful professionals struggle here at Rho.  Rho has a very flat organization structure that relies heavily on project teams’ ability to execute in a fairly independent way.  That allows a high degree of autonomy but also creates higher expectations for collaboration and communication.

Some people love this—they get a great deal of say in both what work they are doing and how they do it.  They don’t feel micromanaged and they enjoy close collaboration with their teams.  Some people don’t love it—some people prefer more firm direction and less fluid hierarchies.  If you need a lot of structure and close oversight from a supervisor to be successful, this may not be the best environment for you.  If you don’t like being part of a self-directing team and want a manager to negotiate your work priorities and interactions with other groups, this may not be the best environment for you.  There’s nothing wrong with that!  There are plenty of places that operate that way, but Rho is not one of them.

Why we do it

Rho super heroesWe believe our employees are our greatest asset.   Attracting and retaining the most talented employees is critical to our success, so we put a huge emphasis on selecting the right people to join us and maintaining a culture where talented people want to stay long-term.  

A number of years ago, we went through a period of accelerated growth where we hired a large number of people very quickly.  Despite carefully vetting the technical capabilities of these individuals, a high percentage failed to succeed here.  We began to experience a lot of turnover—a new and unpleasant problem.  The culture and work environment began to drift from what had made us successful and what had made many of our long-term employees so excited about working here.  It took a lot of effort to correct that drift and stop the turnover, but we did it—and we don’t want to have to repeat that effort.  

We now view maintaining our culture as another key component to continued success.  Culture fit interviews are one way we do this.  It is a significant investment we are making—it takes a substantial amount of time to conduct these interviews and it means we sometimes can’t grow as quickly as we might otherwise.  It is also a step in the selection process that we take very seriously.  We never skip this step, and we don’t make an offer to a candidate unless the culture fit interviewer is satisfied.

How can you prepare?

rho_portraits_Spencer-080Are you interested in working at Rho, but this part of the interview process makes you nervous?  Here’s some advice to help you prepare.  This isn’t supposed to be a “gotcha” process.  It is supposed to help us—and you—evaluate whether this is a working environment where you can be successful.

Start by reviewing our core values.  All of the questions we ask directly relate to these values.  Think about examples and stories from your past experiences that demonstrate your strengths in relationship to each of these values.  Think about some examples that show:

  • Times when you’ve gone above and beyond to help your team or a coworker succeed
  • Clever ways you’ve solved complicated problems
  • Situations where your integrity has been tested
  • Ways you’ve ensured the quality of your work

Don’t worry if you don’t have a lot of work experience to draw from.  We’ve had plenty of early career candidates who have answered our questions with examples from school projects, internships, volunteer experiences, and extracurricular activities.  

Interested in learning more about working at Rho?  Find out more about why Rho is a great place to work or meet some of the interesting people you could be working with.

View Opportunities

What Makes a SuperheRho: More Than a Coworker in a Cape

Posted by Karley St. Pierre on Tue, Nov 14, 2017 @ 09:33 AM
Share:

“Who’s your favorite superhero?” No matter your age or gender, this question is commonly asked. It’s an ice-breaker of sorts—a response can tell a lot about someone’s personality and values. There are the typical, almost obvious answers—Batman, Superman, etc. Maybe you’d have a Marvel enthusiast throw in Iron Man for good measure. Or you could have someone aptly choose Wonder Woman as their favorite, what with this year’s blockbuster film making great strides in its genre. Regardless of who you choose the idea behind it is the same: who is someone you look up to, someone who can do anything incredibly. Superheroes are often thought of as being larger-than-life, having these unbelievable powers and instincts. They make great characters because their attributes are so incredible and uncommon. Yet, what we often forget is that we actually have superheroes around us every day, in real life—and at Rho. Between conducting clinical trials, giving keynote speeches at conferences, and participating in local philanthropy events, employees at Rho consistently go above and beyond. So, it comes as no surprise that we showcase our superhero staff when the time is right.

This past September, Rho celebrated being named to the Triangle Business Journal’s “Best Places to Work” list for 2017. The local publication holds nominations each year and honors the winners at a celebratory luncheon. Rho has been fortunate to receive this honor for 6 consecutive years, and each year Rho’s attendees choose their favorite hero-inspired shirt to wear. “When I was asked what character I wanted to be, at first I thought it was silly,” said Lane Bissett, a Business Development Associate with Rho. “Of course, I picked Wonder Woman like all the other ladies, but when I put on the shirt, it hit me.” Lane said that seeing herself alongside her Rho teammates, all wearing their chosen superhero tees, put an idea in her head. “We all are so different, but we all have these qualities that make us work great as a team. Representing Rho as this unified group of people felt really surreal.” Much like superhero squads in the movies, our team at Rho consists of many different personalities, strengths and talents. Whether it be a Clinical Research Associate or a Clinical Project Manager, every Rho employee has the opportunity to showcase their skill and knowledge while also learning from others. It’s a kind of collaboration that not only works but can be hard to find. 

21762788_1889648361053166_2032741538705477340_o.jpg

It’s this idea that makes Rho special—this unification of people and personalities towards one purpose and goal.  At Rho, that core purpose is to improve health, extend life, and enhance quality of life through corporate and research excellence. Each employee who represented Rho at the Triangle Business Journal Luncheon came from different sectors, holding different positions within the organization. “I was really proud when the announcers mentioned how Rho has won for the past 6 years,” said Joyce Lau, Research Associate. “It made us all feel kind of invincible,” she continued, “and it made me realize that there is a reason we can call ourselves superheroes here. We definitely had the most spirit, and it showed!” Throughout those 6 years, Rho has continued to see tremendous growth and opportunity, especially when it comes to adding more superheroes to the team. “When I came to Rho, the first thing I noticed was how great the people are,” Lane added. “Every day I feel lucky to work with the people I do, and it makes me excited to think of new hires joining and getting to see how amazing we are.” 

Shortly after Rho was honored at TBJ’s luncheon, we also celebrated our fiscal year end. At the celebration, employees were able to enjoy delicious food, interact with our CEOs and founders, and take home some pretty awesome Rho backpacks. “It felt like an early Christmas,”  said Joyce. “It just goes to show how much the people at Rho really care about you, really going above and beyond what you’d expect.” The year end celebration was a superhero convention it its own way—all our phenomenal heroes in one place.

FullSizeR.jpg

It’s not just the luncheons and gatherings that make us excited and proud to wear the title of “SuperheRho.” Just like the characters in comic books, every day brings a new challenge to face and every day we get to use our strengths to rise to the occasion. Recognition can be nice, but that’s not why superheroes do what they do. There’s an internal push for excellence and success, which Rho mirrors in our core values. So when we get asked who our favorite superhero is, chances are it’s someone here at Rho.

 

50 Must Have Travel Tips from Experienced CRAs

Posted by Brook White on Wed, Oct 25, 2017 @ 09:57 AM
Share:

Recently, I sat down with Clinical Team Leads Caitlin Hirschman and Jamie Christensen who have a combined 25 years of monitoring experience to learn more about the travel tips they’ve acquired over the years.  Here’s what they had to share:

luggage and packing

General

1.  Expect the unexpected.  Things will go wrong, so you just have to be patient and stay calm when you are traveling.  Going in with the expectation that everything will go according to plan is a recipe for dissatisfaction.

2.  Get loyal with an airline and hotel chain so you can reap the benefits of their rewards systems (when it isn’t cost prohibitive).  You’ll appreciate the free upgrades and other goodies that you’ll collect over time. 

3.  Have cash. It comes in handy for tips and other small items.

4.  Invest in comfortable shoes.  Wear flats and bring sneakers.

Luggage & Packing

5.  Travel with a backpack and a carry-on.  Using a backpack rather than a purse or tote bag leaves your hands free which will make things much easier.  The backpack can also serve as the go to bag while you are on-site.

6. Invest in a good carry-on.  Consider one that is small enough to fit under the seat if you’ll be going on lots of overnight trips.  That way you won’t have to gate check your bag if they run out of room in the overhead compartments or if you are on a small regional flight that doesn’t accommodate roller boards.

7. Keep a ready-to-go toiletry kit that you don’t have to repack each time that contains carry-on size liquids.

8. Aveeno makes face wipes that work well as a non-liquid facial cleanser.

9. Pack light. A good rule is to pack two shirts for each pair of pants and re-wear the pants.
10. Pack clothes that don’t require ironing.

11. Bring some candy. It can make a good pick me up when you are feeling worn down.
12. Gum can come in handy too.

13. Don’t forget your chargers.

14. De-clutter your wallet so you are only carrying what you really need.

Air Travel

15. TSA pre-check is totally worth it. Not only does it provide the convenience of not needing to take off your shoes and take things out of your bags at airport security, but the shorter lines can save you a lot of time especially at larger airports. (Rho pays for TSA pre-check for frequent travelers).

16. Delta and Southwest are favorites for airlines. If you take Southwest, it’s worth it to pay for the early bird check-in so you get a better seat assignment. The cost will be offset by what you might have spent checking your bag.air travel

17. Consider joining an airline club. It can provide a really nice break during a long layover or if you get stuck because of a flight cancellation. (Rho pays for airline club membership for frequent travelers).

18. In general, aisle seats are preferred, but window seats may be better for a redeye.

19. Make sure to get a seat close to the front of the plane if you have a close connection, even if it means taking a middle seat. A middle seat is definitely preferable to a missed connection.

20. Don’t bring fish or beef jerky to eat on the plane. Your fellow passengers will appreciate it.

21. Avoid connecting flights through New York area airports. Atlanta is a good airport for transfers.

Ground Transportation & Parking

22. Consider using Uber to get from home to the airport depending on how long you will be gone and what time your flights are departing and arriving. It can be substantially cheaper than parking and you get dropped off close to the terminal at most airports.

23. If you do need to park, consider using an off-site parking service. You can earn points, they provide amenities like coffee and newspapers, and drop you off right by the terminal and your car. It can also feel safer than walking through a parking garage late at night.

24. Consider using Uber or other ride-sharing services in cities where parking can be a problem. This may also be a good plan if your visit is at an academic site. University parking is notoriously problematic.

25. If you have a good taxi driver, get their card so you can use them for the rest of the trip or future trips to the same city. It also allows you to call ahead for a ride.

Hotels

26. Download a noise machine app. It can help you sleep better in new places—particularly noisy ones.

27. Don’t sleep naked. You never know when there will be an unexpected hotel fire alarm.

28. When visiting a new site, ask them for hotel and restaurant recommendations.

29. Ask for a higher level hotel floor (never ground floor).

Health and Wellness

30. Bring an empty refillable water bottle and then fill it once you are on the other side of airport security. It’s easy to get dehydrated while you are traveling, and this is an easy, cheap, and environmentally-friendly solution.

31. Bring snacks. You never know when you are going to be stuck somewhere that it isn’t convenient to get food or where food options aren’t great. You can also choose healthier snack foods when you pack them yourself rather than purchasing them at the airport.

32. Make a plan to get in a workout wherever you go. It is easy to ignore your health when you are traveling frequently. Bring workout clothes and sneakers.eat healthy when you travvel

33. Check with your gym to find out if they have satellite locations in areas where you frequently travel.

34. Some hotels offer workout clothes and shoes that you can rent.

35. Keep your sneakers in your backpack, so you can take a walk and explore the city after work.

36. Keep hand sanitizer or baby wipes handy. Planes and airports are germy places.

37. Look under the mattress to check for bedbugs.

38. Beach Body Workouts is super cheap for a year membership. Just log onto the app and choose a workout like yoga or T25, which is a super quick great workout.

Safety

39. Make sure someone has your contact information and also knows your travel plans. Make sure to give the airline an emergency contact number. This is especially important for single folks who aren’t necessarily checking in with anyone regularly.

40. When the hotel asks you how many keys you want, always tell them two so that no one overhears that you are traveling alone.

41. Do a safety check of the hotel room before settling in. Check behind doors and in closets where someone could be hiding and make sure windows and sliding glass doors are locked.

42. If you are traveling to a new place, try to arrive when it is still light outside.

Food & Entertainment

43. Headphones for the plane are a must. You can use them to listen to music or movies, and to drown out the noise of the plane (or unruly passengers).

44. Before you leave on your next trip, download movies, books, or audiobooks to entertain yourself on the plane or when you have some free time back at your room.

45. Learn to enjoy travel by exploring each place you go. There are a number of “Best of” apps that tell you the best sandwich, beer, dessert, etc. in each state. It can be fun to see how many you can collect.

46. Some restaurant and hotel chains have happy hours which can save you some money if you are traveling on a per diem reimbursement plan. In some cases, hotel happy hours provide free food that make for a decent light dinner.

47. Bring a bathing suit. If you have free time you can get some exercise in the pool or some relaxation time beside it.

48. Go see landmarks in new cities you visit—the Seattle Space Needle, Millennium Park in Chicago, Duck Tours in Boston, Riverwalk in San Antonio.

49. Baseball games are a great way to take in some local flavor at a reasonable cost.

50. Check out some local restaurants.

What are your best travel tips?  Share in the comments below!

View All Job Openings

12 Resume Tips That Can Help You Get a Clinical Research Job

Posted by Brook White on Wed, Sep 13, 2017 @ 11:36 AM
Share:

resume tips for clinical research jobsI’ve been working at Rho for 10 years and at CROs for more than 15 years, and in that time, I’ve reviewed a lot of resumes for job seekers in many different positions. Here are some resume and CV tips to help you stand out with the recruiters, hiring managers, and interview teams that make the difference between getting an interview or a rejection letter for the clinical research job you really want.

Note: The tips I’m sharing here are for job seekers in the US. International standards can differ.

Keywords Matter

In most cases, the first look at your resume won’t be a thorough one. During that first pass, a recruiter is probably looking for a handful of keywords that they associate with the position. What terms are you using to search for jobs? Those same terms should show up prominently on your resume.

Does that mean you can’t get a job if you haven’t held that job before? No. You just need to make sure that it is clear how your experience is applicable. For example, if you are seeking a job as a CRA but haven’t had CRA as your title, you can still make sure that words like monitoring and site visit show up in the accomplishments and descriptions of your roles. For competitive positions, most candidates are screened out during this step. Make sure you’re not one of them.

Proofread, Proofread, Proofread

I’m always surprised by the number of resumes I see that have basic spelling, grammar and formatting errors. Generally, I wouldn’t consider hiring someone with these sorts of errors. This may sound picky, but clinical research requires close attention to detail for nearly every position at every level.

You should carefully proofread your resume. Then, ask someone with strong writing and editing skills to do the same. Don’t have access to someone that’s up to the job? Check out Grammarly. It is a free online tool that will eliminate most of these errors. Make sure you list the correct company and job title for which you are applyi

best candidate for a clinical research job

ng. Listing either one incorrectly shows a lack of attention to detail and tells the recruiter you aren’t committed to their company.

Tailor Your Resume to the Position

Start by carefully reading the posted job description.  What specific skills and experience does the job require?  Make sure you highlight these skills on your resume and that it is obvious how your experience aligns with the required experience for the job.  What are the primary job duties and responsibilities?  Call-out how you have accomplished similar tasks in your previous work.  Finally, review the company’s website to see what values they highlight.  Quality? Teamwork? Fast-paced environment?  Think about how you can demonstrate the attributes they are looking for in the materials you are submitting.  This may seem daunting, but submitting 10 tailored resumes will produce better results than submitting 100 generic ones.  List your applicable skills at the beginning of your resume, not the end.  You want to capture the attention of the resume reviewer quickly.  

Demonstrate Knowledge of the Industry

Whether you are a clinical research veteran with 20 years of experience or are seeking an entry level position, your resume should reflect awareness of what is happening in the industry. If you are new to the industry or returning to the industry, there are a number of great free news sources that can help you with this. A few of my favorites are FierceCRO and FierceBiotech, Clinical Leader, and Applied Clinical Trials.

Consider how to work in key trends. Searching for a clinical operations role? Highlight your experience with risk-based monitoring. Looking for a job in clinical project management? Mention your experience working with patient advocacy groups to improve patient recruitment. Obviously, the depth of knowledge and awareness expected will differ based on your role and experience level, but these are the kinds of things that can be differentiators in a competitive field. One thing to note – make sure you can speak to every item on your resume if asked about your experience – no fabrications. If you can’t articulate that particular skill or ability during an interview, don’t list it on your resume or CV.

Formatting

This is not a creative or design-focused industry.  Your resume does not need to be a work of art, but basic proper formatting is expected.  Use an easy to read font and font size with a light background color and a dark font color.  Have reasonable margins.  Use bullets.  Limit your resume to 2-3 pages maximum.  Focus on making it easy to read and easy to find desired information.  There are plenty of good free templates out there, so consider using one of those if you aren’t sure what good formatting looks like.

Cover Letter—Yes or No?

happy_business_colleauges.jpgWhether or not to include a cover letter depends both on your resume and the position for which you are applying. In some cases, it will be obvious how your skills and experience are transferable to the posted position. For example, you currently are a clinical data manager with experience in EDC system x and skills y and z applying for a job as a clinical data manager with experience in EDC system x and skills y and z. In this case, a cover letter isn’t necessary, although it would provide an opportunity for you to explain why you are interested in that company or that position.

In some cases, there isn’t a straight line between your work experience and the position you’re applying for. Or, maybe there is something on your resume that you would like to explain like a gap in your work history. Or, maybe the position is in another location and you want to voice your willingness to relocate. A cover letter can help you with any of these situations. If you do include a cover letter, make sure it is concise, well-written, and offers something more than what would be obvious from reading your resume. And don’t forget to ask a friend to proofread your cover letter! A great resume will be overlooked by a poorly written and grammatically incorrect cover letter.

Accomplishments Not Duties

For each position, you should include a brief summary of the responsibilities followed by a couple of core accomplishments.  It should not be a bulleted list of the twenty duties in the job description.  Finally, accomplishments should be specific and should include metrics where possible.  For example, a clinical project manager might list an accomplishment like “For a global phase 3 study, completed enrollment 6 weeks early and delivered topline results 3 days after database lock.”  This resume will get a lot further than one with a list that says managed global phase 3 studies, oversaw data management and statistical deliverables, and managed timelines.

Technical Skills

Recruiters and hiring managers are often looking for specific technology skills and even experience with specific software systems.  Ideally, these would be listed in the job posting, but that isn’t always the case.  Include both industry system types like CTMS, EDC, IRT, and statistical programming languages as well as specific system names like Medidata Rave and SAS.  Also include industry agnostic technologies that may be applicable to your role like MS Project, HTML, or Java.  If you have experience in clinical research, you should also list the therapeutic areas where you have experience. Also make sure to list any certifications like the Regulatory Affairs Certification (RAC), Project Management Professional (PMP), or Certified Clinical Research Associate (CCRA).

How Long Should My Resume Be?

The answer to how long your resume should be depends on how much work experience you have and the type of job you are seeking.  For recent graduates and early career candidates, about a page is a good rule of thumb.  For experienced candidates in most roles, 2-3 pages is an appropriate length.  For scientific roles where publications are expected to be included, CV length is highly variable and should be driven by career length, number of professional positions, and number of publications; however, you still want your biggest selling points on the first couple of pages.

Things You Don’t Need to Include on Your Resume

There are also a number of things you shouldn’t include on your resume:

  • Personal or demographic information like age, race, gender, religious preference, social security number, or marital status.
  • Photos.
  • Salary history or salary requirements.
  • “References available on request”—this is assumed, takes up space, and can make your resume seem dated.
  • Objective—I’ve never seen an objective that has made a difference in my decision for the positive.  However, an objective that isn’t well written or doesn’t align with what I’m looking for has caused me to rule candidates out.

Advice for Recent Graduates

Many recent college graduates struggle with what to include on their resumes besides their education if they don’t have professional work experience.  That is totally fine—when we are hiring entry level candidates we don’t expect them to have professional work experience.  Some beneficial things you can include are:

  • Volunteer experience
  • Non-professional work experience from restaurant jobs to dog walking to mowing lawns in the summer
  • Study abroad programs
  • Internships
  • Extracurricular activities, especially leadership positions
  • Class projects that are relevant to the position

Each of these provides valuable information about you.

Interested in working at Rho? Learn more about working at Rho!

View All Job Openings