Big Pharma has taken a lot of heat in light of a nationwide opioid epidemic. But Pharma is a term that encompasses far more than painkillers, and there are many exciting developments taking place under the Pharma umbrella. Some of these trends may ultimately lead to cures that humanity desperately needs.
These industry insiders have witnessed these trends, and they gave us their best projections as to how these trends will shape the future of Pharma. Here's what they have to say:
1. VIvek Ramaswamy, founder and CEO of Roivant Sciences
“One positive trend we are seeing is regulatory approvals for transformative one-time therapies including gene therapies and regenerative medicines. Our healthcare system is designed around reimbursements for chronic care, not single-administration cures, but we are beginning to see new models for amortized payments over longer time horizons, including value-based pricing where insurers only pay if a given therapy works.
One negative trend is an industry-wide focus on immuno-oncology to the exclusion of other disease areas. We have witnessed significant advancements in the treatment ofcancer over the past decade, but comparatively little progress in developing innovative treatments for neurodegeneration, diabetes, obesity, and other conditions which are significant drivers of healthcare costs in the developed world.”
2. Dominic Viola, Executive Director, Client Services at W2O Group
“Knowledge is power. Pharma is focusing more and more on the collection of data to shape every decision they make. From understanding which products to develop to predicting which patients will benefit most from those therapies. No longer are the days of a “one size fits all” treatment approach. Based on a set of criteria, derived from the data we collect, we can now provide a more customized treatment plan that will drive a more predictable result for each individual patient.”
3. Shital Mars, CEO of Progressive Care
“Costs and pricing models are the driving force in Pharma development. More bioidenticals and biosimilars are going to come to market which will push prices downward. Pressure on sale pricing is forcing reevaluations on development costs as more manufacturers grapple with investments into new drugs for more lucrative disease states. Pharmacies themselves are being squeezed from all angles including decreased reimbursement rates, increasing drug prices, and increasing back end fees. These costs are leading many to close or consolidate to survive.”
4. Mark Emalfarb, CEO of Dyadic
“There are an increasingly large number of collaborations taking place this year between companies that are innovating novel production platforms for vaccines and drugs on the one hand, and actual vaccine and drug manufacturers on the other hand.”
5. Paul Tunnah, founder and CEO of Pharmaphorum
“There are three core trends shaping pharma in 2019 – digital, precision medicine and the focus on outcomes.
Digital is impacting lots of areas, from marketing / communications engagement, through advanced analytics / AI impacting research and development and into areas like digital medicines and ‘beyond the pill’ support.
Precision medicine continues to grow, as we understand the genetic basis for disease in small patient segments and tailor targeted therapies to them, plus embrace treatments tailored at individual patients, such as CAR-T cell therapy.
The focus on outcomes is being driven by health systems and patients, where reimbursement for medicines is being assessed increasingly on the value they deliver in the real world, and on meaningful outcomes for patients, rather than clinical trial results.”
6. John Bermudez, General Manager of Digital Network Platform at TraceLink
“The key trends shaping the Pharma industry in 2019 are being driven by the need for traditional pharma companies to reshape themselves to develop and deliver new products based on Cell and Gene Therapies. The current wave of new Cell and Gene Therapies called CAR-T therapies show enormous potential but also require big investments to bring to market. The financial challenges of this reshaping are large for pharma companies, CDMO’s and CRO’s. Bristol Meyers Squibb’s acquisition of Celgene is an example of the investments being made and also a concern for CRO’s as dollars shift from research contracts to acquisition of startup biopharma companies. This will also require that CDMO’s invest in new manufacturing facilities to produce and deliver these new therapies and will likely drive further consolidation of CDMO companies. To address the financial challenges, all segments of the pharma industry are looking to new technologies to help reduce the gross inefficiencies that have plagued the industry. These new technologies include artificial intelligence (AI), healthcare tech (where patient-reported outcomes are integrated into smartphones and wearables), blockchain (to ensure the integrity of the complex multi-party processes in Cell and Gene Therapy), and end-to-end supply chain visibility to increase the agility and flexibility to deliver these new therapies.”
7. Melonie Warfel, VP and General Manager, Life Sciences at Model N
“The focus on price transparency, exemplified by the expected changes to HHS Safe Harbor regulations in the US, is leading life science manufacturers to develop new business models that provide patients with long term access to products at stable prices. Chronic disease and vulnerable patients are most affected by price increases and the target of these new business models, such as subscription drug pricing. Manufacturers are looking to increase access to treatment while improving medication adherence and driving patient loyalty, which allows them to build lifelong revenue streams while improving outcomes for these patients by making treatment more affordable.”
8. Barby Ingle, President of the International Pain Foundation
“In 2019, the change I see is pharmaceutical companies restructuring. Especially in the pain community. The days of them working with our community leaders and progressively changing lives on a macro level are going away. We will see them working on an individualized level. I am not sure if this is good or bad for society over all. As a nonprofit leader, it is tough to see them pulling back. As a patient, I know that change is needed and better options are coming from these changes.”
9. Andrew Ittleman, Attorney at Fuerst Ittleman David & Joseph
“I foresee for pharma two trends – one, more convictions of pharma execs operating at the margins of the law; and, two, if pharma companies and their execs are serious about not ending up in John Kapoor’s shoes, there will be serious efforts to create cultures of compliance to avert such costly and reputational disasters. There is no escaping these trends as the federal government is now wise to those dubious gambits and is vigorously scrutinizing such activity.”
10. Ilana Jacqueline, Patient Advocate and Author of Surviving and Thriving with an Invisible Chronic Illness
“From promoting clinical trials to marketing products already approved, Pharma companies are turning to *Real patients, not actors to share their stories in a more authentic approach to reaching patient-consumers. Some companies are hiring patients to give sensitivity training to their entire staff from CEO to hotline representatives and holding workshops where they invite patients for roundtable discussions on how the disease is impacting their life and how their company can make a difference.”
11. Gail Trauco, CEO of The PharmaKon LLC and Front Porch Therapy
“Patient Advocacy is shaping Pharma in 2019. Advocates bridge the connection to patients with therapeutic diseases for clinical trials. Progressive pharma and biotech companies have engaged patient advocates who are influencers and successfully use social media strategies. The new clinical trial formula is:
Advocate + Patient Engagement = Enrollment
Clinical trials are in a competitive environment where patients are able to “shop around.” This is especially important for gene therapy and immuno-oncology trials. Savvy pharma becomes the “Macy’s Santa” with their Advocates who are already known and trusted; thus, opening the door for a clinical trial to be considered by patients.”
12. Kevin Lawler, VP of Sales at Pelican BioThermal
“Going forward, pharmaceutical manufacturers must re-evaluate their cold chain processes to ensure more fragile (biological drug) therapies arrive on time and intact at their destinations. This will likely involve evaluating everything in the cold-chain, from temperature controlled packaging to pack-out procedures to different service levels and modes of transportation. It’s also likely that pharmaceutical companies will look to continue to outsource many of the cold chain strategies that aren’t in line with their core capabilities.”
13. Rutesh Shah, co-founder and CEO of Infostretch
“Seismic shifts are happening in both
backend operations and patient facing engagement models. Backend shifts
include items such as significant M&A activity, changes in strategic partnerships between major health insurers and pharmacy benefit managers (PBMs), and the seemingly inevitable entry of Amazon into the market.
Patients don't typically feel the immediate impact of those transactions, but they do feel the shifts that are more closely tied to their direct engagement with pharmaceuticals. Most often found in the form of digitization, these shifts are starting to hit home in a positive way for patients. For example, RxSense is positively disrupting the Pharmacy Benefit Management market, GoodRx is positively disrupting the traditional pharmacy model and Proteus is positively disrupting pharmaceutical ingestion.”
14. Joel Selzer, Cofounder and CEO of ArcheMedX
“There are a number of trends (i.e., digital enablement, regulatory changes, market competition) that are converging around patient centricity. In clinical research, the need to expand clinical trial recruitment to reach more diverse and hard to reach patient populations is leading to a greater focus on bringing the trial to the patient. It is significantly easier today to reach a larger pool of qualified patients and to mitigate risk in a remote or site-less trial by utilizing digital tools to ensure home health staff is properly trained, patients are enrolled and remain engaged, and clinical data is captured compliantly.”
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