PharmaSource Podcast

Ray Sison is the Managing Partner for SCxCMC, connecting biotech companies with highly qualified CDMOs, strategic consultants and independent contractors.

Changing contract manufacturer is not a decision to be taken lightly, yet can be necessary to take a product to a commercial stage says Ray Sisons.

Ray Sison is the Managing Partner for SCxCMC, a consultant who specialises in connecting biotech companies with highly qualified CDMOs and independent contractors.

In his work with early stage biopharmas, Ray often finds they are managing several contract manufacturers without a formal supply chain strategy or procurement function.

"There's the supply chain you launch with, and then there's the supply chain, you actually will use in day-to-day commercial operations." he says.

"Often when we arrive we find a cobbled together set of Contract Manufacturers (CMOs) that may or may not have had the proper commercial skillset or capacity to meet the long term forecast for the product."

In the latest episode of PharmaSource podcast, Ray Sisons shares his advice on how to manage CMC and Supply Chain partnerships.

Vendor Selection

"From the very beginning, a clear project definition really sets your priorities. You need to know what it is you're trying to outsource, where you are in the business cycle and what's your exit."

"A client that is looking for a 'one stop shop' is very different to a biotech that just needs to get prototypes and preliminary stability work done."

"Bottom line, you need the right voices at the table to set the selection criteria." says Ray.

"It's not just the scientist at the bench that has the final say on who you outsource, you need to talk to your quality, compliance and regulatory. And ,if you have that function set up already, you should be talking to your commercial and supply teams about their objectives."

Ray says it's also important to take into account 'intangible' elements such as corporate culture, leadership quality when selecting a partner.

Deciding when to part company from an existing supplier

"Deciding to cut a CDMO loose may not a comfortable question asked in the presence of a CDMO", say's Ray, but it may be necessary.

"Working with a CDMO is a partnership but it's also a business transaction. If one side fails to deliver, if it does not meet its contractual obligations, timeline or deliverables, then action needs to happen."

Reviewing contractual terms

"We use all the project management and business tools that we have at our disposal before we look at the contract and start taking legal action. If we simply view there should be an exit clause, that's typically where you can get out for cause or without cause."

"The red flag is if one of the sides is no longer negotiating in good faith. If that sounds like a legal term it's because it is. It's the language we use to mean we've got to the place where one or both sides become so frustrated, that they're looking at the language of the contract to see what they're supposed to do next."

"In a functioning relationship, you don't do that - you pick up the phone, you call them and you figure out a way to work it out. But if it’s evident that one of the parties is not acting in good faith, not negotiating that looking to actually solve the problem... that for me is the moment when you decide we need to look elsewhere." says Ray.

Always have a backup

For many smaller companies having more than one CDMO working on a the same product may not be economically viable. However, there is no reason not to have backups on stand-by, says Ray.

"Always have multiples, as part of the vendor selection process. I recommend that you have a primary and you have a backup."

"You negotiate with the primary, obviously, as you want to move forward with them. Make sure to keep a relationship with the backup, even if you don't initially contract with them. That way if things go sideways you have options."

Read the full article on PharmaSource

This episode is a live recording from our first Women in Pharma Procurement meetup.

Pharma is an industry where 90% CEOs are men, and the gender pay gap is still a very real issue. In this session we learned that pay disparity is  no.1 challenge women are facing in their roles.

Since we launched PharmaSource community, it’s been clear that driving a real and meaningful change for women is an area that many of our members are passionate about. 

The panel debate you’re about to hear was chaired by Alicia Ryan, Principal Consultant  Proxima, with Tanya Momtahen,  VP Integrated Product Solutions. Thermo Fisher Scientific, Sharmeen Lalani-Fade, Global Procurement Lead: Online Media & Data, Bayer, along with contributions from members.

To find out more about this session and to get involved in future events, head to /https://pharmasource.global/content/tackling-the-gender-pay-gap-is-the-no-1-challenge-for-women-in-pharma-procurement-video/

1990’s technology stacks will not give us the supply chain that 21st century customers need and deserve, says Elouise Epstein.

Speaking to the PharmaSource podcast, Kearney partner, author and futurist Elouise Epstein explains that “Third-party data exchange is the key to the future. Above all, we need to facilitate easy data exchange with suppliers.”

In her new book, How to Hack the Supply Chain, Elouise describes an experience she had during COVID-19 when was given her vaccination record on a piece of paper. With no digital record, there was no way for her to understand the provenance of the drug she was putting into her body.

“I realised that none of these entities were integrated. There is no data exchange with the third-parties developing and distributing pharmaceuticals.”

This lack of transparency comes with real risk, says Elouise.

“When we extend supply chains we make them brittle and susceptible to risk. Our inability to exchange data has created vulnerability”

Elouise has come to the conclusion that the 21st supply chain technology platform should based around cloud technologies that are able to facilitate data exchange with third-parties, rather than the Enterprise Resource Planning (ERP) systems that currently represent the foundation of most pharma supply chains.

Read the full article on PharmaSource

How should a 100 year-old pharma company partner with a tech giant such as Google?

Sharmeen Lalani-Fade, Global Procurement Lead for online media, creative and data for Bayer explains how they are partnering with Google to bring their Advertising technology (AdTech) stack in house.

The project is designed to connects the 'demand side' (Bayer's marketing campaigns) with the online advertising 'supply side' (websites that show as such as Google, YouTube etc) - without the need of advertising agencies.

"The goal of the project is to be less reliant on agencies and more accountable" says Sharmeen.

“The holy grail of procurement is cost transparency. When you're buying everything through a media agency, however good they are, they're just not built to give you transparency. “

There were challenges with 100 year old company trying to interface with a new breed tech company.

“Not all advertisers directly contract with tech platforms." says Sharmeen "It's a decision that a company can't really take lightly. It requires a great deal of upscaling of the organisation… marketing, procurement, accounts payable all need to go on the digital journey together”

As Sharmeen explains, the project "required a great deal of due diligence. You need to be prepared for some of the common pitfalls".

7 takeaways from the Bayer / Google partnership for procurement professionals.

1. Aim for a true strategic partnership

2. Educate yourself about the tech landscape

3. Help the supplier to understand your world

4. Ensure contracting processes align

5. Marketing effectiveness has to be measured in-house

6. With great data ownership comes great responsibility

7. Stay strongly aligned with stakeholders

Read the full article here:

Avantor is a Fortune 500 company with a wide range of mission-critical products and services for the biopharma industry.

David Coorey, SVP Biopharma Business Development & Commercial Operations at Avantor spoke to the PharmaSource podcast to explain more about the services they offer.

David explains how Avantor supports biopharma companies through R&D scientific discovery, to scale up and full commercial GMP manufacturing materials including custom use excipients and single use consumables.

“Avantor’s has evolved a unique ‘systems approach’ to designing full Fluid handling solutions for customers” says David. “We work with customers to design and optimise a solution that’s tailored to their unique manufacturing process” rather than a rigid, one-size-fits-all approach.

Avantor operates in more than 30 countries, with 14,500 globally. In addition Avantor’s channel brand, VWR offers an integrated, seamless purchasing experience that is optimised for the way our customers do business.

Read the full article here

Brian Whitlock, Vice President of Global R&D Procurement at Bristol Myers Squibb shares his experience in building a high-performance operating model to support the business objectives of biopharmaceutical research.

In the latest episode of the PharmaSource podcast Brian explains how the procurement operating model had to change following 2019, when BMS announced the acquisition of Celgene.

“The acquisition was a sea change for how we think about procurement, and how to support a much larger critical R&D business unit with 9,000 scientists worldwide.” he says.

Procurement had to align with the priorities for the wider Bristol Myers Squibb business: building a world class pipeline, improving productivity and reducing development cycle times while also delivering high quality medicines to our patients.

In order for procurement to support this, Brian explains that “There has been a lot of process reengineering, both internally and with our partners, but also tapping capabilities that exist within the supplier market, that perhaps we have not made a direct investment in.”

Brian worked with leaders within R&D function to design an operating model that “not only focuses on driving the high volume, high risk and high visibility opportunities but also have individuals with unique skill sets that can drive an innovation portfolio.”

“Procurement played a very important role sitting at the table with our stakeholders to bring those new capabilities to our enterprise.”

“One of the things I absolutely love about R&D is we have very creative scientists that come up with challenging opportunities. Every day is different. Every challenge is a little bit unique. It’s that variation, and the complexity of these challenges that really motivate us day to day.”

The conversation covers the follows:

Full article here

The contract manufacturer has eight manufacturing facilities spread across China, and delivers “500-600 projects a year, with 50 assets available for western markets,” says Jon Brice, Senior Vice President of Business Development at Asymchem Group.

In this interview with the PharmaSource podcast, Jon explains that what makes Asymchem unique is their two flagship technologies:

“If you look at the suite of technology we’ve developed, it’s a toolbox you can’t find at any other CDMO,” Jon adds.

“We interact with 18 of the top 20 market cap pharma companies in the world, and the one topic that comes up at every meeting is sustainability. It’s really started to accelerate over the last 9-12 months.”

Five years ago, sustainability was more of an aspiration. Now, it’s a legitimate interest with real progress being made. Companies are now required to prove their commitment to sustainability, with each having their own scorecard and tracking metrics.

Asymchem’s flagship technologies position them perfectly to deliver value against these sustainability goals.

“1 in 2 projects we do uses a biocatalytic step with an Asymchem enzyme,” Jon explains. Biocatalysts (sometimes called nature’s catalysts) provides a legitimate avenue of progress in making processes greener.

“Flow processes are inherently less polluting as they allow for the recirculation of reactive streams on a small amount of solvent, using less polluting materials. These processes are inherently de-risked, leading to fewer accidents, less flammable material, and less risk of running foul of environmental agencies.

Last year, Asymchem were awarded the inaugural ACS Award for CMO Excellence in Green Chemistry for leveraging innovative manufacturing technologies to deliver sustainable processes.

“The client wanted us to change their existing manufacturing processes to flow chemistry.” says Jon. ” It was their insistence and their driving criteria for vendor selection move away from waste-producing methods and to do this in sustainable way.”

Skyepharma is a fully-integrated CDMO specialised in formulating, developing and producing complex oral dosage forms and expanding into Bioproduction with the opening of their new SkyeHub plant.

Based outside Lyon, France, the company offers their worldwide customer base a full range of services, from early stage development to industrial manufacturing and packaging.

Following a management buyout in 2021, SkyePharma is now fully owned by its management team.

In the latest episode of the PharmaSource podcast Skyepharma CEO David Lescuyer and Chief Business Officer Laurent Rigaudeau discuss the transformation journey the company is on.

“The management buyout allowed us to continue on our growth path as an independent French company.” says David.

“Now when a client meets the management team, they also meet the owners of Skyepharma. We are truly committed to the projects of our clients”.

A significant milestone for the CDMO is the recent completition of Skyehub, their new bioproduction plant, developed in partnership with MaaT Pharma.

“Skyehub was answer to something that was missing in the market.” says David, explaining how they have been working with MaaT Pharma since 2018 and together conceived a facility that could finalise the development of their product under GMP conditions for commercial use.

The plant is owned by SkyePharma, and available for other companies from early 2024.

“We had to build a brand new biotech plant with clean rooms inside, ready to build to the latest genomes. We had to implement the right quality system that allows them to produce under GMP conditions, and it all had to be delivered in in 13 months.”

Hitting these goals “was a huge challenge” says David, but the project was delivered on time and to budget.

In addition, over the last two years Skyepharma have adapted their facility to the production of Highly potent APIs (HPAPI), says Laurent.

“We have built a dedicated building for research and development of HPAPIs.  The next exciting project for us is to launch a fully dedicated new area to expand our services into more complex molecules and oncological products.”

World Courier, a specialist in logistics, warehousing, and transportation services for the pharma and biopharma industry, covers the entire supply chain from preclinical stages and universities to commercial products.

With 50 years of experience in the storage and transportation of time and temperature-sensitive products, World Courier is part of the Cencora group (formerly AmerisourceBergen), allowing it to tap into a wider range of services.

Alan Runacus, UK Sales Manager, explains how World Courier supports pharma and biotechs of all sizes to access important markets.

“World Courier is not just about delivering packages; we ensure that products and samples get to where they need to be at the correct time and temperature for quality.”

As an example, World Courier holds licenses in all 52 states in America, facilitating storage and distribution.

“This makes it easier for European organizations trying to launch in the US or small Biotechs who simply don’t have the scale to apply for them all individually. World Courier can take that on and distribute direct to pharmacies.”

World Courier has been delivering direct-to-patients for over 20 years and today has a dedicated global team for personalised supply chains.

“The market has evolved significantly in recent years” says Alan. “Our network now includes more cryogenic stations around the world. We use liquid nitrogen shippers, the mode of choice for Cell & Gene therapies.”

“We were the first to introduce GPS in all our multi-use packaging systems. Clients can click into an online portal to see where their package is. “

“These therapies have made everybody look at packaging solutions to deliver safety and integrity of the product because it’s going back to a patient. “

Read the full article

SUANFARMA provides Contract Development and Manufacturing (CDMO) services for fermentation and chemical synthesis projects – both generic and innovator.

The company offers a ‘One Stop Shop’ service helping customers to achieve success in the development, scaling, manufacturing, and commercialization of APIs.

David Blanco Industrial Business Development & CDMO Director, explains the services that they offer to customers.

“SUANFARMA is more than just a CDMO, we are a real strategic partner for success in achieving customers’ final goals. We have a flexible mindset and full transparency with customers, providing them with tailored solutions to meet specific needs.”

“We specialise helping pharmaceutical, biotech and healthcare companies by delivering fully integrated services that compress timelines to market. We provide global solutions that enable customers to achieve their objectives with high quality at affordable cost, including full regulatory support for FDA and EMA.”

The pharma industry needs CDMO partners to be flexible with manufacturing due to changing market dynamics, says David.

“Our flexibility and transparency are highly valued by our customers, we adapt to changes that arise during the project accommodate, batch size requirements and guarantee the capacity on time as per the business plan.”

David explains that a key differentiator for SUANFARMA is offering a single European manufacturing plant can combine GMP, industrial processes of fermentation, purification and chemical synthesis services.

“Centralisation of commercial manufacturing processes at a single site simplifies the supply chain and thus achieves highly attractive costs, minimises risk and optimises time.”

The sustainability footprint is also improved as the site including access for full waste recycling, use of green power, and the use of green chemistry to reduce environmentally harmful processes.

Innovative solution for wastewater treatment

SUANFARMA’s ground-breaking Pharmaceutical Wastewater Treatment Project has led to them being nominated alongside their partner e-Watts have been nominated for the 2023 CPHI Awards in the Sustainability category.

“It’s the world’s first large scale installation that treats industrial volumes with a flow rate of up to 250 m3 per hour.” says David.

“Our innovative solution is an improvement of existing wastewater treatment technologies that often rely on dangerous chemicals or incineration, which can be harmful to the environment.”

“We use electro-oxidation which doesn’t require the use of dangerous chemicals and can remove non-biodegradable compounds and pollutants from volumes of wastewater, making it a much more efficient and eco friendly option.”

In addition, the plant generates green hydrogen as a by-product of the electrolysis process, which can be used as an energy source to reduce the facility’s dependency on external energy sources.

Read the full article here