Two Labs Blog

Two Labs Blog

Michael Rowe Joins Two Labs as DSCSA (Serialization) Compliance Services Manager

Posted by Two Labs on September 3, 2019

At Two Labs, we value partnership. We work hard to make sure our clients view us as an extended part of their team, and not just another vendor. As the pharma market continues to evolve, we are excited to expand our team so that we can provide even more value to our clients as they navigate the path of bringing their products to market. 

Two Labs welcomes Micheal Rowe to the team as our new Serialization Services Manager.

Michael Rowe

As we evaluate the ways that we can best grow and serve emerging pharmaceutical manufacturers, we realize that there is a great need and opportunity to advise clients on the Drug Supply Chain Security Act (DSCSA) regulations and timeline.

Michael comes to Two Labs after working at Cardinal Health for 11 years, most recently serving as the Manager of Operations Technology, where he oversaw Cardinal Health’s track and trace serialization program and advised on DSCSA requirements. His new position at Two Labs will expand the scope of our serialization services to work with more clients as well as downstream with all trading partners.

“There are few people who can understand and advise on the many complexities of DSCSA like Michael can,” said Rich Wartel, Founder and CEO of Two Labs. “His serialization expertise, combined with his experience in project management, sales analytics, operations and customer service in the pharmaceutical manufacturing industry will offer our clients unmatched guidance as they navigate through the DSCSA and bring their new drugs to market. Beyond his skills, he has a true passion for teaching and communicating on the subject, which is extremely valuable in our industry.”

IconBook-0519v1

Michael is well-known for his DSCSA expertise and has spoken at several industry conferences and events, including the Healthcare Distribution Alliance’s Traceability Seminar and their Distribution Management Conference, Pharma IQ’s Pharmaceutical Traceability Forum and DSCSA seminars with GS1. He has also participated in several industry task force groups.

 

IconGears-0519v1

Along with helping clients meet the current requirements, Michael is looking ahead to future challenges and opportunities of the DSCSA, including the saleable returns requirement and how to efficiently handle the mass amount of necessary communication and serialization checks; how blockchain’s information storage capabilities could benefit manufacturers and wholesalers; and the analytics possibilities that exist when the kinks have been worked out and the industry is equipped with mass amounts of serial data. 

“The opportunities at Two Labs, both for the industry and for me personally, are so exciting,” said Michael. “I am also excited to work alongside so many innovative and intelligent people with the common goal of helping emerging manufacturers bring their medicines to patients who need them.”

Topics: DSCSA, Two Labs, Trade, Pharma Consulting

7 Top Pharma Trends for 2017

Posted by Jessica Krauser on February 7, 2017

From the effects of Donald Trump’s election as US president to pioneering therapies for Alzheimer’s, some trends are set to continue and others to emerge as the global pharmaceutical industry pushes into 2017.

Analyzing the top seven pharma trends forecast for the new year, Pennside Partners offers some key insights into the essentials.

 

Pharma Trend #1: High-tech pharma

With inhalers that track doses and products that monitor patient compliance, high-tech in medication is becoming increasingly important. “The big thing that strikes me is how pharma is becoming more and more dependent on medtech,” commented Dr. Munna Choudhury of AlacraMed in an interview with Life Science Investing News. These technological additions give a product its competitive edge, according to Choudhury. The article highlights that as a result, we could see more collaborations between pharmaceutical companies and unlikely players, such as telecoms companies and mobile device manufacturers. With support from these tech firms, pharmaceutical manufacturers can develop holistic products to support applications including diagnostics, monitoring, and compliance.

Similarly, PharmaPro expects companies to unlock the potential of AI, Big Data, and Cloud technologies to support their supply chains, predict outcomes, and prescribe actions autonomously – offering significant promise for return on investment. PharmaPro said: “In 2017 these advancements will continue to evolve to make the entire supply chain autonomous.”

 

Pharma Trend #2: New treatments for Alzheimer’s

As the baby boomer generation grows older, the Alzheimer’s Association predicts Alzheimer’s Disease (AD) to account for almost 25% of Medicare spending by 2040 – a huge increase over the predicted 2.1% of Medicare spending in 2020. So far, the pharmaceutical industry has not discovered an optimal response to the disease. According to Forbes.com, although billions of dollars have been invested in targeted antibody drugs, the trend is likely to shift towards alternative scientific approaches in 2017.

One theory is that Alzheimer’s can be fought by preventing the immune system from removing synapses required for neuronal functioning. The article also highlights that an anti-inflammatory drug reportedly improved memory in a small set of patients with mild cases of AD.

 

Pharma Trend #3: Political uncertainty in the UK

A significant carry-over trend from 2016 is the political uncertainty following Brexit. According to Pharmafocus, significant consequences of the UK leaving the EU on the pharmaceutical industry could be regulatory. The article explains that for a drug to be placed on the EU market it must have a marketing authorization (MA), which may be granted by the European Medicines Agency’s recommendation to the European Commission.

Alternatively, applications may be considered by a ‘reference member state’ (RMS) residing in the EU. Once approved by that country, the other EU RMS should grant national approvals. It is not yet clear whether the UK could continue to be the RMS for authorized products after it leaves the EU. For more analyses of the possible consequences of Brexit, click here.

 

Pharma Trend #4: The Trump Effect

In addition to UK and EU market uncertainties, the US is anticipating its own economic policy uncertainty with the election of Donald Trump as president. Trump’s plans appear to be a mixed bag for consumers and Big Pharma alike because it is nearly impossible to gauge their potential impact. Trump’s health plan states: “Reform the Food and Drug Administration, to put greater focus on the need of patients for new and innovative medical products.” According to The Washington Post, this represents a hint that the drug and medical device industries may soon have an easier time getting products to market. Robert Weissman, president of Public Citizen, countered, “…the general deregulatory rhetoric…is a worry for us, but as applied to FDA, it would be very troubling,” meaning that deregulation may compromise safety standards.

Trump has also pledged to cut corporation tax for American companies, with The Telegraph reporting that this move could trigger significant pharma mega-mergers. Furthermore, Trump has suggested he would allow businesses to repatriate money earned overseas into the US without facing hefty fines.

Yet, Trump has intimated that he would allow the importation of high-price medications from abroad, where they are cheaper, notes The Telegraph. This would result in parallel markets entering into direct competition with the US market. While it is impossible to foresee where these proposed reforms will take the economic and regulatory aspects of the pharmaceutical industry, it will be vital to have a finger on the pulse.

 

Pharma Trend #5: Drug prices

The end of 2016 saw several major pharma companies sued for allegedly fixing drug prices, and public outcry in the face of pricing is likely to continue into 2017. Pharmaceutical consultant Carole Bruckler told Pharmaceutical Investment News: “In the US, there is clear political will forming against annual or quarterly drug price increases to fuel sales growth.”

Although the election of Trump is likely to prove more favorable to drug prices than a Clinton victory would have – under Trump, we could see reduced regulation on drug price inflation – pharma companies may have to reconsider their business models, warns the article. Bruckler added, “For pharma revenues to be sustainable in the future there needs to be an increased focus on volume growth … so investors need to really understand the substance behind their investments.”

 

Pharma Trend #6: Biosimilar profitability

Biosimilar drugs present a more affordable option for the consumer and are also potentially lucrative for manufacturing companies. Importantly in 2017, these biological products are set to continue to increase in popularity. Since the first biosimilar drug was approved for use in America in 2015, there are now more than 700 biosimilars approved or in the pipeline. Sales could be boosted by 11 key biologics that face loss of exclusivity over the next seven years, with biosimilar sales expected to generate 27 per cent of the total pharma market by 2020.  

 

Pharma Trend #7: The microbiome

DNA sequencing tools that have boosted understanding of how we exist with the bacteria in our guts has brought the microbiome to significant prominence in biology over recent years. Research suggesting that the bacterial composition of the gut affects mood opens up new avenues for the treatment of depression and other mental illness or disorders of the central nervous system. However, according to Forbes.com, how biotech and pharma companies can develop drugs based on this science is an open question – despite development in that direction.

Topics: Pharma Trends, Pharma Consulting