Tag: Life Science

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Product launch excellence in biopharma

Posted on May 24, 2017 - 12:00 am by

The biopharma industry is facing many challenges – and opportunities – at present, including increasing complexity in the market and the continued increasing pressure on managing costs amidst thinner pipelines. This means successful launch planning and execution for new products becomes more critical than ever.

Current challenges in launch planning

Five trends in particular are changing the landscape of new drug launches, creating potential obstacles that must be carefully considered at the launch planning stage (see Figure 1).

Figure 1: Current challenges in new product launches

Fewer blockbusters

While companies used to launch a few large products each year, they are now launching many small-to-mid size products instead, with more intense competition. This growing emphasis on small-to-medium-revenue products means that biopharma companies are developing wider and more fragmented product portfolios than ever before. In turn, product launches increasingly need to be tailored and customized to suit diverse product types. Additionally, this means that there is stronger pressure for a quicker return on investment (ROI).

Doing more with less

With continuous pressures on bottom-lines, there is an overwhelming need to ‘do more with less’. Diminishing firm-wide launch capabilities mean launch resourcing is often sub-optimal. Balancing speed-to-market with proper launch preparation is putting more pressure on resources than ever before. In such an environment, adaptability is often the key to success.

Rise in specialty launches

The majority of new launches are increasingly targeted to smaller patient populations, and around half of new drugs approved in the US in 2015 were specialty medicines. By their very nature, specialty drugs require much more targeted launch efforts and a highly customized approach, which means launch teams face a steep learning curve. Biosimilars in particular present a new level of complexity in the specialty market.

Focus on value and outcomes

There has been a strong shift towards a greater focus on value and outcomes, driven by the increasing importance of functions such as Health Economics and Outcomes Research (HEOR), managed care account management, and patient advocacy services. Payers increasingly are putting pressure on coverage and drug reimbursement, sometimes even restricting access for patients.

Acceleration of innovation cycle

As product technology development cycles have shortened over time, companies need to continuously plan to think and stay ahead. This dramatic acceleration of innovation means products typically have less time on the market to recoup investment.

Plus, as shown in the Figure 2, on top of all these challenges, pharma companies are navigating incredibly complex customer landscapes.

Figure 2: The complexity of the customer landscape

 

This environment shapes the key success factors in launching a new drug

To successfully launch a product in this challenging landscape, pharma companies must build the following success factors into their launch planning efforts:

  • A comprehensive and robust launch framework is needed to capture all the key launch activities and structure them in the most effective way.
  • Approaches must be customized and tailored for each type of product.
  • Initiatives and processes must be prioritized depending on the launch stage and type of product (critical path mapping).
  • Resources must be allocated intelligently, particularly when it comes to the flexibility of resource onboarding and offboarding.
  • A risk-management and scenario-driven approach is vital.
  • Strong PMO support is needed to manage an integrated launch effort across functions, and with stakeholders and external partners.

Providing a three-pillar framework for successful launch planning

At a-connect, we have found that a simple, three-pillar framework helps biopharma companies develop a structured, robust, integrated launch plan, as shown in Figure 3.

Figure 3: Three-pillar framework for launch planning

A foundation of strong capabilities in each of these areas is critical to the success of the launch. With this in mind, across the three pillars, we have identified a set of key modules (20+) of key activity components that encompass multiple functions vital for a successful launch.

a-connect has been supporting several biopharma companies in different capacities for their product launches. Examples of this include:

  • Launch preparation support when our clients face critical capacity and capability gaps across key functions, such as marketing, brand planning, pricing and market access, market assessment/research, forecasting, sales, and medical affairs. We deploy seasoned professionals who have real-world pharma launch experience in a variety of complex, cross-functional environments across a range of therapeutic areas to provide hands-on support and leadership.
  • Project management/PMO support to drive creation of an integrated plan and robust launch preparation by working together with cross-functional stakeholder teams and driving critical path planning of key launch milestones.

Conclusion

While the shifting biopharma environment no doubt presents challenges for those charged with launching new products, it does present opportunities for those who can proactively adapt their launch planning and execution to suit changing markets and products. Please contact us to learn more about a-connect’s capabilities and how we can support your product launch.

Patients not patents – new times spell new solutions for the pharma industry

Posted on March 29, 2018 - 1:23 pm by

“I was terrified – I thought I was losing my mind and felt totally alone.” Behind a double-sided mirror and far from my usual domain of slides and spreadsheets, I sit with my project team listening to a patient describe the moment of crisis following a cardiac event. She touches on her distrust of the health system, the journey towards recovery and the impact of her health on her personal relationships.

The client: a global pharma company. The goal of our exercise: understand patient pains and design a commercially attractive solution to address them. The remit: it cannot be a drug or drug related.

In a business where individual blockbuster can turn millions of dollars of revenue a year, this remit may seem astonishing. However, it is a recognition that ongoing industry change is putting intensifying pressure on the traditional road to success. Returns to R&D are falling, stretched health systems are challenging prices, and payer consolidation is further decreasing the bargaining power of pharma companies. Simultaneously, rapid advances in Internet of Things, bioelectronics and data science present both new opportunities and competitive threats.

In response, pharma companies are exploring a range of strategic options. Some of these involve improving operations through more advanced use of technology and data: for example, designing trials that leverage remote monitoring to decrease cost and trial cycle times, or using advanced data analysis to extract new learnings from existing collected data. Another direction is looking at new business models, such as outcomes based payment whereby a payer only pays the full price of the drug if it meets pre-defined performance targets. Finally, many firms are exploring new types of offerings aimed at patients, payers, or health care providers.

Many pharma companies today have explicit goals around patient centricity. Traditionally, this has entailed improvements that increase drug adherence, the single most important lever for improved patient outcomes as well as a driver for pharma sales. In the old world, this focused on developing pills that could be taken in a single daily dose as opposed to multiple doses throughout the day; in the digital world, it involves experimenting with e.g. adherence apps and smart pill bottles that prompt the patient to take their daily medicine and enable tracking of adherence over time.

However, as our project showed, pharma companies are also looking further afield in their quest to get closer to the patient. Onduo, a joint venture between Sanofi and Verily (Alphabet’s health company) is virtual diabetes clinic with services delivered through phone and app that centers on coaching and promoting a broad spectrum of health interventions to supplement existing physician care. Pfizer’s oncology business has launched support programs that offer users of their medicines access to tools or a team of social workers to support them in living with their disease.

These ventures are not only new to pharma companies – they are new to patients. Although the internet and health related apps have enabled a certain dilution, the patient relationship is still largely “owned” by the health care provider, who often also is the default custodian of patient data. This means that new types of players vying for an active role in patients’ lives need to slot themselves into this ecosystem, or disrupt it – with the likes of Apple, Amazon and Verily entering the game, the latter is a real possibility. This may be more difficult for pharma companies, who treasure their relationship with health care professionals and are less eager to displace them.

Moreover, while the broad health care industry is excited about the shift towards patient centricity, creating viable new businesses off its back comes with challenges for pharma. Firstly, there are questions of the business model. Who is willing and able to pay for new products, services and solutions – patients, payers or caregivers? Then there is the question of how they should be priced – should they be bundled with a drug, priced as cost-plus, or should they be priced relative to the savings they can generate for a payor or provider? Additionally, there is the cultural change of treating patients like true consumers. Oftentimes, if I were in a pharma focus group session, I would be looking through my one sided glass not at patients, but at doctors, with the goals of figuring out how to best market the pills. Now, the focus is rather on understanding the real pain points of patients and trying to design a solution for them. This is an altogether different approach to ideation, creation and marketing compared to the core pharma business.

With myriad partnerships and initiatives launched in the past couple of years, these new offerings have yet to prove themselves; in particular they will need to demonstrate not only that they are viable, but that they are commercially attractive compared to the core drug business. However – and as I experienced on my project – it is a fantastic, rewarding journey for anyone given the opportunity to work on these challenges. In the meantime, patients have something to look forward to: being front and center in the future evolution of the healthcare and pharma industries.

The Parallel Lives Of Our IPs #6

Posted on February 8, 2019 - 9:24 am by

1. How would you describe your current family situation?

I am married and have three teenage children and a cat. We live in Central London and have a large extended family – none of which lives in the UK, unfortunately. So there’s a lot going on – the kids all go to different schools and we tend to go back and see family in Sweden as often as we can. Both my husband and I work full-time, and always have done.

2. What does a typical day look like and what types of family decisions do you make on a daily basis?

I am often away – I’ve always worked full-time, so the family has to function without me around, and that works very well. The kids get up around 06.30am, wolf down a quick breakfast and leave the house between 7am and 7.15am. My husband and I often walk with one of them to the bus stop/train station when we can. Three times a week, we have help to clean up after breakfast, sort the house out and help with the laundry. The kids get home between 5pm and 8pm, depending on after-school activities. The eldest (16) is responsible for washing all of their clothes and the younger two (14 and 13) are responsible for making dinner. Sometimes it works, sometimes it doesn’t. My husband gets home between 7pm and 8pm most nights. If I am in London, I often do not get back until later, as I tend to work from a workspace. We do not eat together as a family during the week, and the kids do their own homework and revision without much daily support from us. During the evenings, we often help them with applications for orchestra camps, ordering new school uniform, paying for martial arts lessons, setting up new computers, planning instrument grading exams or revising for major things like GCSEs. Having three teenagers is like helping three slightly lost adults who do not quite know how to organize their very active lives yet.

As I am not around much, it’s not really possible for me to make decisions on a daily basis when away from home. We’ve got different areas of responsibility and I can’t really influence what goes on at home on a daily basis. Inevitably, my husband does a lot of what needs to be done there and then, and I am responsible for things that can be done online. I am responsible for ordering all the food for the family and making sure there is enough of everything. This often results in us having ten liters of milk but no butter or cheese. I also do some of the admin that can be done via email, such as dialogue with other parents and shopping for uniforms or sheet music. But I can’t say I really make many decisions on a daily basis; decisions need to be made jointly in advance and the rest of the family manages the household.

3. How do you achieve a work–life balance as a parent?

I don’t. No parent does to the extent they’d like to. But I try! My husband and I constantly prioritize and talk about how to organize the family. We’ve set up structures around us that enable everything to function with both of us working, but a lot of compromises are required.

I have learned a lot from others about how to organize a home with two working parents, and I try not to compare myself with others. I accept all the help I can get to make things work at home. Personally, I have not tried to change the way I work much. By being an IP, I can sometimes take time off between projects, which has been a great benefit.

4. What are the biggest challenges you encounter, both at home and at work? And how do you get around them?

I’ve chosen to take the challenges mainly at home rather than at work. We have set the family up to work without me around and created a flexible support structure that has adapted as the kids have grown.

When it works, it’s great, but it doesn’t always work. I had prepared myself for the inevitable “Why are you never home like other mummies?” before it came, so it probably hurt less. And it’s not been frequent; as the children grow, they see the benefits of having two working parents.

I know that I don’t work well in a 9-to-5 environment. I like challenging and complex projects and fast-changing environments. I tried for many years to work less, but I always found it hard. As an IP, I can manage this by either working or not. For me, alternating periods of intense work with time off works better than trying to manage my hours.

5. What advice would you give to IPs with families?

Accept that it requires effort from everyone involved

It can be demanding on everyone to be part of a dual-career family. I have a super-supportive husband who luckily doesn’t travel much with work, and the kids are used to me not being around. They have had to take on more responsibility and be more independent than if their parents had been able to be there every day and every evening. When I’m around, I tend to go to all the school events I can, as, for long periods, I can’t attend anything and my husband may have to go to four school concerts in one week. I can’t recommend highly enough marrying someone who agrees with having a dual-career family if that’s what you want. Otherwise, I don’t see how it could work.

Prioritize and don’t compare yourself with others

It’s a matter of prioritizing and accepting that some areas of life will be a mess for part of the time. But that’s probably better for me and the family than trying to organize everything perfectly. Most mothers in my area don’t work, and there is no way I can do the bake sales, charity fundraisers, coffee mornings and wine tastings that some of the other parents regularly engage in. It just can’t happen with my work and travel schedule, so I try not to compare myself with the neighbors. Be honest with yourself and your partner about what you want to achieve and what you’re going to have to leave.

Agree expectations

For me, it’s been important to be clear with all my family that, when I’m working, I can’t expect to be part of all the decisions and everything going on. I don’t have to speak to my kids or my husband on a daily basis because I trust them to get on with it and let me know if I’m needed for anything. They don’t count on me during the week, and I don’t interfere. I have time to focus on the project at hand, and can stay away an extra day if needed without the world falling to pieces. I don’t get upset if I miss an important event, unless I have taken a day off. I don’t try to plan anything at the end of the day when I’m working – I rarely make it out on time. On the other hand, I try to limit weekend work as much as I can.

In my work life, I’ve been clear about what my availability is and what travel and working hours are acceptable. However, I’ve generally taken the approach of creating a support structure that enables me to do whatever I need to do at work rather than impose limits on which projects I can take.

Allow some extra capacity and slack

Work–life balance isn’t only about work and daily family routines – it’s also about the social structures and planning that comes with family life. I found that setting ourselves up for the predictable demands isn’t enough; there’s slack needed because, in the middle of it, life happens. Planning holidays, supporting a sick parent-in-law, moving house, changing schools, researching tutors for GCSE revision, planning a 40th birthday party or supporting a friend through a divorce doesn’t happen all the time, but there’s generally always some sort of crisis brewing. The setup has to provide for some unpredictability and extra capacity, because it is needed more often than not.

Accept all the help you can get/afford

We used to have an au pair when the children were little and we needed someone to walk them to school. We also have a wonderful multitask cleaner who’s been with us for 10 years and we send our children to our parents for the school holidays. When the kids were little, we had plan A (a parent home), plan B (an au pair home), plan C (a grandparent/babysitter home) and plan D (an emergency childcare agency already set up to come at a moment’s notice). Yes, I used plan D once, handing a baby and house keys over to a stranger to make a flight on time. If you ever think you may need to be able to do this for work, it’s a good idea to set the structures up in advance.

The Parallel Lives Of Our IPs #8

Posted on May 22, 2019 - 12:00 am by

1.  When you are not working as an IP, what do you do?

I am fortunate enough to have cultivated several hobbies to make the transition to full time retirement smooth, including golf, snowboarding, scuba diving, and handicapping horse races. However, I would say that my greatest passion is racing horses as a partner in Zilla Racing Stables.

2.  How did you come up with the idea of doing professional horseracing? 

I grew up close to the Saratoga Racetrack in Saratoga, NY, which is one of the most prestigious racetracks in North America.  My father, being a hardcore racing enthusiast, took me on many summer days to watch and bet on the races. Back then, if you were tall enough to reach the betting window, you were old enough to bet. Although I never really rode horses (attempted to learn once in my 20s but a broken wrist cured me of that urge), I have always loved horses and watching them train and play. They are just amazing creatures. Add to that the thrill of cashing a ticket, and I was hooked pretty quickly.

When I was in college, my father organized a group of his friends to purchase horses. I will never forget my first time going to Belmont Park to watch our first horse, Individual Lad, run. When he crossed the finish line in front, I literally could not control my excitement and I knew at that moment that I would own horses myself someday. That day came 30 years later when my father, after being out of racing ownership for the last 25 years, decided to organize another group of friends to get a few horses. Our group had six wins over about 18 months, including the father-son moment I will never forget when our horse Hot Splash romped home to a 9-length victory. At the time, we thought she would become a star (unfortunately, she did not) and it was quite a thrill to see a horse we picked out win in the way that she did.

3.  What are the biggest challenges in horseracing?  And why do you find this activity rewarding?

Unfortunately, racing thoroughbreds makes owning boats look cheap, and our group soon realized it was not practical to continue at the level we wanted given the cash we could collectively contribute. Fortunately, this was around the time that public racing syndicates became more prominent, and I became a part of one of the best ones out there, Zilla Racing Stables. Now, instead of buying 20% of a horse, I buy 3% of a horse. This makes the economics far more palatable, and I began buying horses with Zilla about 2 years ago. My Zilla posse has achieved 13 wins in 64 starts so far.  This includes a thrilling victory won by a nose, resulting in a $200K prize in the Fleet Indian Stakes at my hometown track last August, with my very first Zilla purchase, English Soul. It was a lifelong dream come true and I was positively giddy for a month afterwards. I still get goosebumps watching the replay 6 months later and I am sure that I will never get tired of watching it.

4.  How do you think this pastime will evolve for you in the future?  Will it become a full-time venture for you?

While I would love to be a full-time thoroughbred horse owner, the reality is that I need to work as an IP to support this habit, so I do not see this becoming a full-time venture anytime soon. I currently have 11 horses and expect to add a few more to the posse after the upcoming spring sales, with a goal of keeping around 20 horses at a time by 2020. I typically have 5-10 races a month at present, and I do try to attend most of the races that are held locally though, I must say, that it can sometimes be a challenge managing the IP work and getting to all the races!

Digital Transformation in the Pharmaceutical Industry: A Case Study

Posted on December 12, 2019 - 12:00 am by

The problem: raising awareness of our client’s lung cancer therapy

A top five pharmaceutical client was looking to boost their new lung cancer therapy, which was suffering from slow adoption. Research had shown that awareness of the therapy was low among physicians, who were uncertain about which patients were appropriate candidates for the therapy and which health plans covered it. When the client launched the treatment, they invested heavily in key areas – for example, promoting the therapy at conferences, in publications, and through Medical Science Liaisons (MSLs), Salesforce and multichannel marketing (including new digital channels). Despite this, the client was struggling to get physicians to use the treatment. This is because the lung cancer therapy space is so crowded and multi-tiered that it has led to physician inertia and confusion about the best therapies for individual patients.

We assessed the situation and found that, when multiple therapies are launched for the same condition, physicians are often not aware of the latest therapy guidelines around which option to choose. Even when newer therapies are more appropriate for a certain subset of patients, physicians often continue to use the established therapies for the majority of patients. Physicians treat a large number of conditions and, as such, it is not always possible for them to remember the intricacies of each treatment – regardless of how much the client invests in driving awareness.

Electronic health records can boost awareness of treatments at point of care

One of the newest channels that is helping to boost awareness of new therapies among physicians is the electronic health record (EHR). Due to the Affordable Care Act (ACA), there has been large-scale adoption of EHRs in both inpatient and outpatient settings over the past decade. EHRs are now the primary screens that providers use to manage their patients. The data that providers enter into EHRs – along with other data, such as lab results and imaging data – can be used by physicians to determine the best therapy for individual lung cancer patients. EHRs offer a channel to remind physicians of the various treatment options at the point of care, enabling them to decide on the best therapy for the patient, based on the treatment guidelines and FDA labels.

Our solution: best practice alerts for decision support at point of care

We determined that it would be possible to implement EHR-based decision support at the point of care, using decision support software that is integrated within the EHR. This software allowed us to write clinical rules for lung cancer that used EHR data to trigger a best practice alert (BPA) to remind them about the best therapy for the patient at the point of care.

We carefully studied many elements when designing the clinical prediction rules, including treatment guidelines; the types of data physicians use when deciding on a lung cancer treatment; which EHR fields contain the data; and physician workflows.

Following the launch of the BPAs, we noticed significant engagement by physicians and a clear change in treatment patterns.

The benefit of real world data to both pharmaceutical companies and providers

The above example shows how real world data (RWD) is helping pharmaceutical companies transform their business models. Traditionally, pharmaceutical companies have only had access to research data and clinical trial data – it was not possible to access RWD, such as claims data or data from EHRs. Now, physician workflows are increasingly becoming digital, and almost all of the data is available in the EHR. As such, pharmaceutical companies can access data that has historically eluded them, which is transformative in terms of developing new treatments, improving clinical trials and commercializing treatments. RWD can also help them identify new indications for their marketed products, since they can monitor how the treatments impact the patients on an ongoing basis. RWD is equally beneficial for providers, who can get better support from pharmaceutical companies – not to mention a new source of revenue from de-identified data sharing arrangements. It is a win-win for the pharmaceutical industry and the providers.

The challenges of accessing RWD

Getting access to RWD is not easy, as many providers are concerned about privacy issues and exposing their patients’ identities. De-identifying the data is not easy either, as much of it is in an unstructured format. As such, many providers are uncomfortable with data sharing arrangements.

As technology improves and safer ways of data sharing become possible, more providers should be willing to enter into data sharing arrangements. There are already organizations that allow pharmaceutical companies to remotely access data from a large number of medical centers in the aggregate for the purposes of clinical trial site identification, protocol design and research. Pharmaceutical companies will need this type of data as they venture into the realm of machine learning for drug discovery, clinical trial management and various other applications.

The importance of taking steps now for the future

The future of the pharmaceutical industry will be heavily influenced by digital technologies and clinical data. It’s critical that pharmaceutical companies take steps now to build internal capabilities in these areas, as well as partnerships to secure access to large amounts of RWD.

 

About Ron

Dr. Ron Razmi is a digital health specialist. He brings extensive clinical, business and technical expertise to addressing key issues facing healthcare organizations today. He began his career as a cardiologist and was one of the pioneers in the application of MRI systems in managing cardiac patients. He built the software system cardiovascularmri.com to educate and train cardiologists in using MRI systems to manage their patients. As a McKinsey consultant, Ron worked with the world’s top life sciences companies across strategy, M&A, and product development. In 2011, he founded Acupera, a population health management software company. This unique platform enables healthcare organizations to use data, care pathways, and AI to industrialize key aspects of care delivery and patient management. Ron completed his medical training at the Mayo Clinic. He holds an MBA from Northwestern University’s Kellogg School of Management.

 

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